1. Ingeniería

Profile
Type
CITY
STATE
Country
Scheme
A & M Biomedical
Single
Laguna Hills
CA
USA
ISO 13485:2003
Contract manufacture and distribution of non-sterile and sterile, non-active and active medical devices.
A.J. Precision, Inc.
Single
Agawam
MA
USA
ISO 9001:2008
The Manufacturing and Assembly of Precision Machined Components.
A.L.I. Label Systems
Single
Galt
CA
USA
ISO 9001:2008
Design, Manufacture and Sales of Tags and Labels.
AADCO Medical Inc.
Secondary
Randolph
VT
USA
EN ISO 13485:2012
IS EN ISO 13485 Scope: The Design, Manufacture and Distribution of Non-Sterlie Gel Pads and Positioners for Patient Positioning during Medical
ExaminationISO 9001:2008 Scope: The Design, Manufacture and Distribution of Ergonomic X-Ray Protective and MRI Safe Medical Equipment and
Devices
AADCO Medical Inc.
Primary
Randolph
VT
USA
EN ISO 13485:2012
IS EN ISO 13485 Scope: The Design, Manufacture and Distribution of Gel Pads and Patient Positioners, Conventional and MRI Safe Examination Lamps
and Ceiling Suspension Systems for Medical ExaminationISO 9001:2008 Scope: The Design, Manufacture and Distribution of Ergonomic X-Ray Protective
and MRI Safe Medical Equipment and Devices
Single
Dublin 14
Ireland
ISO 9001:2008
AAREN Scientific France
Secondary
Paris
France
EN ISO 13485:2012
The Design and Development, Manufacture, and Distribution of Intraocular Lenses.
AAREN Scientific, Inc.
Secondary
Ontario
CA
USA
EN ISO 13485:2012
The Design and Development, Manufacture, and Distribution of Intraocular Lenses.
AAREN Scientific, Inc.
Primary
Ontario
CA
USA
EN ISO 13485:2012
The Design and Development, Manufacture, and Distribution of Intraocular Lenses.
Single
Co Sligo
Ireland
EN ISO 13485:2012
The design, manufacture, sterilization and distribution of adult and paediatric enteral Feeding kits, including tubes, connectors and feeding bags, and the
servicing of enteral feeding pumps.
ACM Machining, Inc.
Primary
Rancho Cordova
CA
USA
ISO 9001:2008
Contract machine shop for the manufacture of metal components for the oil and gas industry, automotive filtration and general machining.
ACM Machining, Inc.
Secondary
Rancho Cordova
CA
USA
ISO 9001:2008
Contract machine shop for the manufacture of metal components for the oil and gas industry, automotive filtration and general machining.
Single
San Jose
CA
USA
EN ISO 13485:2012
COMPANY
Aalto Bio Reagents Ltd
Abbott Ireland
Acronics Systems, Inc.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Scope
The supply of biological raw materials to the in-vitro diagnostics industry
ISO9K Scope: Contract Manufacturing and Assembly of Quick-Turned Low and High Volume Printed Circuit Board used for Military and Wireless
Communication Systems.ISO13485 Scope: Contract Manufacturing and Assembly of Printed Circuit Boards for the Medical Device Industry
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
Actiontec Electronics, Inc.
Secondary
Colorado Springs
CO
USA
TL 9000 R5.0/5.0
TL9000-HSV Scope: Design, Distribution, Support and Servicing of Broadband Products for Telecommunications Service Providers for the following
service categories: 6.2.3.2 Wireless Data Modem, 7.5.1 Technical Assistance and Customer Support Centers.ISO 9001 Scope: Design, Distribution,
Support and Servicing of Broadband Products for Telecommunications Service Providers.
Actiontec Electronics, Inc.
Primary
Sunnyvale
CA
USA
TL 9000 R5.0/5.0
TL9000-HSV Scope: Design, Distribution, Support and Servicing of Broadband Products for Telecommunications Service Providers for the following
service categories: 6.2.3.2 Wireless Data Modem, 7.5.1 Technical Assistance and Customer Support Centers.ISO 9001 Scope: Design, Distribution,
Support and Servicing of Broadband Products for Telecommunications Service Providers.
Actiontec Electronics, Inc.
Secondary
Fremont
CA
USA
TL 9000 R5.0/5.0
TL9000-HSV Scope: Design, Distribution, Support and Servicing of Broadband Products for Telecommunications Service Providers for the following
service categories: 6.2.3.2 Wireless Data Modem, 7.5.1 Technical Assistance and Customer Support Centers.ISO 9001 Scope: Design, Distribution,
Support and Servicing of Broadband Products for Telecommunications Service Providers.
Acumuladores Industriales EnerSys
Secondary
Barcelona
Spain
ISO 9001:2008
Manufacturing of lead acid cells for reserve power industrial batteries. Sales and installation of reserve power industrial batteries.Assembly, sales and
after sales of motive power industrial batteries and chargers. Through its manufacturing plant and Head Offices in Zamudio and its branches in Spain.
Acumuladores Industriales EnerSys
Secondary
Madrid
Spain
ISO 9001:2008
Manufacturing of lead acid cells for reserve power industrial batteries. Sales and installation of reserve power industrial batteries.Assembly, sales and
after sales of motive power industrial batteries and chargers. Through its manufacturing plant and Head Offices in Zamudio and its branches in Spain.
Acumuladores Industriales EnerSys
Secondary
Valencia
Spain
ISO 9001:2008
Manufacturing of lead acid cells for reserve power industrial batteries. Sales and installation of reserve power industrial batteries.Assembly, sales and
after sales of motive power industrial batteries and chargers. Through its manufacturing plant and Head Offices in Zamudio and its branches in Spain.
Acumuladores Industriales EnerSys
Secondary
41008 Sevilla
Spain
ISO 9001:2008
Manufacturing of lead acid cells for reserve power industrial batteries. Sales and installation of reserve power industrial batteries.Assembly, sales and
after sales of motive power industrial batteries and chargers. Through its manufacturing plant and Head Offices in Zamudio and its branches in Spain.
Primary
Vizcaya
Spain
ISO 9001:2008
Sales and installation of reserve power industrial batteries. Sales, assembly and aftersales of motive power industrial batteries and chargers.through its
facilities and Head Offices in Zamudio and its branches in Spain.
Adhesive Packaging Specialties, LLC
Single
Peabody
USA
AS 9100 - C
Adhesive Research Ireland Ltd
Single
Raheen, Limerick
Ireland
EN ISO 13485:2012
ADTRAN GmbH
Secondary
Munich
Germany
ISO 14001:2004
Design, development, product management and related activities of Broadband Access related telecommunication products and solutions.
ADTRAN GmbH
Secondary
Bruchsal
Germany
TL 9000 R5.0/5.0
Design, development, product management and related activities of Broadband Access related telecommunication products and solutions.
ADTRAN GmbH
Secondary
Greifswald
Germany
TL 9000 R5.0/5.0
Design, development, product management and related activities of Broadband Access related telecommunication products and solutions.
COMPANY
Acumuladores Industriales EnerSys, S.A.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
MA
Scope
The Custom Packaging of Single and Multi-Component Adhesive Systems for Aerospace and Industrial Applications.
The design and development, and manufacture of adhesives, adhesive-coated films, laminates and other specialty films for use in the medical devices
industry.
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
ADTRAN GmbH
Secondary
ADTRAN GmbH
COMPANY
Country
Scheme
Munich
Germany
TL 9000 R5.0/5.0
Design, development, product management and related activities of Broadband Access related telecommunication products and solutions.
Secondary
Bruchsal
Germany
ISO 14001:2004
Design, development, product management and related activities of Broadband Access related telecommunication products and solutions.
ADTRAN GmbH
Secondary
Greifswald
Germany
ISO 14001:2004
Design, development, product management and related activities of Broadband Access related telecommunication products and solutions.
ADTRAN GmbH Facility
Secondary
Berlin
Germany
TL 9000 R5.0/5.0
Design, development, product management and related activities of Broadband Access related telecommunication products and solutions.
ADTRAN GmbH Facility
Secondary
Berlin
Germany
ISO 14001:2004
Design, development, product management and related activities of Broadband Access related telecommunication products and solutions.
TL 9000 R5.0/5.0
ISO 9001 2008 scope:The design and manufacture of digital telecommunications equipment and associated software.TL9000- H,S scope:
TL 9000-HS R5.0/R5.0 for the following hardware and software product categories: 1.2.2.1 Wireline, 1.2.9.3 Access Routers, 3.1.2.1 Enclosures, 3.2.2.1.1
Metallic Carrier Systems, 3.2.2.1.2.1 SONET/SDH Transport Systems, 3.2.2.1.3 Microwave, 3.2.2.2 Loop Carrier, 3.2.4.1 Legacy DSL, 3.2.4.2 Symmetric
DSL, 3.2.4.3 Asymmetric DSL, 3.3.4 WLAN Base Station Equipment, 4.2.2 On-line Non-Critical Operations Support Systems, 6.2.4 Digital Data Service
Units, 6.2.5 Passive Optical Network Termination Units, 6.2.7 CPE Router, 6.4 Private Branch Exchange (PBX).
ADTRAN Inc.
ADTRAN India Pvt Ltd
ADTRAN Networks Canada, Inc.
ADTRAN Networks Pty Ltd.
ADTRAN Optical Systems Group
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Secondary
Secondary
Secondary
Secondary
Secondary
Burlington
STATE
MA
Hyderabad
Kanata
Melbourne
Phoenix
USA
India
ON
Victoria
AZ
Canada
Australia
USA
TL 9000 R5.0/5.0
TL 9000 R5.0/5.0
Scope
ISO 9001 2008 scope:The design and manufacture of digital telecommunications equipment and associated software.TL9000 - H,S scope: TL 9000-HS
R5.0/R5.0 for the following hardware and software product categories: 1.2.2.1 Wireline, 1.2.9.3 Access Routers, 3.1.2.1 Enclosures, 3.2.2.1.1 Metallic
Carrier Systems, 3.2.2.1.2.1 SONET/SDH Transport Systems, 3.2.2.1.3 Microwave, 3.2.2.2 Loop Carrier, 3.2.4.1 Legacy DSL, 3.2.4.2 Symmetric DSL,
3.2.4.3 Asymmetric DSL, 3.3.4 WLAN Base Station Equipment, 4.2.2 On-line Non-Critical Operations Support Systems, 6.2.4 Digital Data Service Units,
6.2.5 Passive Optical Network Termination Units, 6.2.7 CPE Router, 6.4 Private Branch Exchange (PBX).
ISO 9001 2008 scope:The design and manufacture of digital telecommunications equipment and associated software.TL9000- H,S scope:TL 9000-HS
R5.0/R5.0 for the following hardware and software product categories: 1.2.2.1 Wireline, 1.2.9.3 Access Routers, 3.1.2.1 Enclosures, 3.2.2.1.1 Metallic
Carrier Systems, 3.2.2.1.2.1 SONET/SDH Transport Systems, 3.2.2.1.3 Microwave, 3.2.2.2 Loop Carrier, 3.2.4.1 Legacy DSL, 3.2.4.2 Symmetric DSL,
3.2.4.3 Asymmetric DSL, 3.3.4 WLAN Base Station Equipment, 4.2.2 On-line Non-Critical Operations Support Systems, 6.2.4 Digital Data Service Units,
6.2.5 Passive Optical Network Termination Units, 6.2.7 CPE Router, 6.4 Private Branch Exchange (PBX).
TL 9000 R5.0/5.0
ISO 9001 2008 scope:The design and manufacture of digital telecommunications equipment and associated software.TL 9000-HS R5.0/R5.0 for the
following hardware and software product categories: 1.2.2.1 Wireline, 1.2.9.3 Access Routers, 3.1.2.1 Enclosures, 3.2.2.1.1 Metallic Carrier Systems,
3.2.2.1.2.1 SONET/SDH Transport Systems, 3.2.2.1.3 Microwave, 3.2.2.2 Loop Carrier, 3.2.4.1 Legacy DSL, 3.2.4.2 Symmetric DSL, 3.2.4.3 Asymmetric
DSL, 3.3.4 WLAN Base Station Equipment, 4.2.2 On-line Non-Critical Operations Support Systems, 6.2.4 Digital Data Service Units, 6.2.5 Passive Optical
Network Termination Units, 6.2.7 CPE Router, 6.4 Private Branch Exchange (PBX).
TL 9000 R5.0/5.0
ISO 9001 2008 scope:The design and manufacture of digital telecommunications equipment and associated software.TL 9000-HS R5.0/R5.0 for the
following hardware and software product categories: 1.2.2.1 Wireline, 1.2.9.3 Access Routers, 3.1.2.1 Enclosures, 3.2.2.1.1 Metallic Carrier Systems,
3.2.2.1.2.1 SONET/SDH Transport Systems, 3.2.2.1.3 Microwave, 3.2.2.2 Loop Carrier, 3.2.4.1 Legacy DSL, 3.2.4.2 Symmetric DSL, 3.2.4.3 Asymmetric
DSL, 3.3.4 WLAN Base Station Equipment, 4.2.2 On-line Non-Critical Operations Support Systems, 6.2.4 Digital Data Service Units, 6.2.5 Passive Optical
Network Termination Units, 6.2.7 CPE Router, 6.4 Private Branch Exchange (PBX).
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
COMPANY
ADTRAN, Inc.
Profile
Type
CITY
STATE
Country
Scheme
Primary
Huntsville
AL
USA
ISO 14001:2004
The design and manufacture of digital telecommunication equipment and associated software
Scope
Primary
Huntsville
AL
USA
TL 9000 R5.0/5.0
ISO 9001 2008 scope:The design and manufacture of digital telecommunications equipment and associated software.TL9000 - H,S scope: TL 9000-HS
R5.0/R5.0 for the following hardware and software product categories: 1.2.2.1 Wireline, 1.2.9.3 Access Routers, 3.1.2.1 Enclosures, 3.2.2.1.1 Metallic
Carrier Systems, 3.2.2.1.2.1 SONET/SDH Transport Systems, 3.2.2.1.3 Microwave, 3.2.2.2 Loop Carrier, 3.2.4.1 Legacy DSL, 3.2.4.2 Symmetric DSL,
3.2.4.3 Asymmetric DSL, 3.3.4 WLAN Base Station Equipment, 4.2.2 On-line Non-Critical Operations Support Systems, 6.2.4 Digital Data Service Units,
6.2.5 Passive Optical Network Termination Units, 6.2.7 CPE Router, 6.4 Private Branch Exchange (PBX).
Advance Medical Designs
Single
Marietta
GA
USA
ISO 13485/CMDCAS
The design and development, manufacture and distribution of sterile and non-sterile disposable patient drapes, equipment covers, medical waste bags,
high pressure lines, pressure monitoring lines, decanters and related devicesfor infection control and fluid management.
Advanced Programs, Inc.
Single
Salem
NH
USA
ISO 9001:2008
AdvanDx
Single
Woburn
MA
USA
I.S.EN ISO13485:2012
Advant Medical Ltd
Single
Co. Galway
Ireland
EN ISO 13485:2012
The contract assembly, manufacture and packaging of non-sterile medical devices including guidewire and catheter dispensers.
AeroGen Ltd
Single
Co. Galway
Ireland
ISO 13485/CMDCAS
CMDCAS & MD: The design, development and manufacture of Medical Devices and Systems for Systemic Diagnosis, treatment and drug delivery.
Airmar Technology Corporation
Single
Milford
NH
USA
ISO 9001:2008
AirXpanders, Inc.
Single
Palo Alto
CA
USA
ISO 13485/CMDCAS
AIXTRON
Single
Sunnyvale
CA
USA
ISO 9001:2008
The design, manufacture and service of Thin Film capital equipment for advanced semiconductor manufacturing.
AIXTRON, Inc.
Single
Sunnyvale
CA
USA
ISO 14001:2004
The design, manufacture, service and marketing of thin film capital equipment for advanced semiconductor manufacturing.
Alden Medical, LLC
Single
West Springfield
MA
USA
ISO 13485:2003
ISO 9k scope:Design, Manufacture, and Distribution of Osmometry Calibration Standards for the Medical Device Industry, and Sanitization Products for the
Agricultural Industry.ISO 13485 scope: Design, Manufacture and Distribution of Disinfecting & Cleaning Agents, and Disinfectant Indicator Solutions for the
Medical Device Industry.
ADTRAN, Inc.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
The design, production and integration of high assurance solutions and hardware to the United States Government.
The design, manufacture and distribution of In-Vitro Diagnostic devices used for rapid detection and identification of bacteria and yeast in blood cultures.
The Design, Manufacture and Service of Ultrasonic Transducers and Transceivers, Sensing Instrumentation and Signal Processing Electronics.
The design, manufacture and distribution of active implantable tissue expansion systems for breast reconstruction applications
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
Alfa Scientific Designs, Inc.
Single
Poway
CA
USA
ISO 13485/CMDCAS
Allard Support UK Limited
Single
Co Louth
Ireland
ISO 9001:2008
Allen Medical Systems
Single
Acton
MA
USA
EN ISO 13485:2012
Alliance Technical Solutions, LLC
Single
Salem
NH
USA
AS 9100 - C
Design and Manufacture of High Reliability Power Conversion Products.
Alloy Metal Products
Single
Livermore
CA
USA
AS 9100 - C
The Manufacture and Assembly of Complex Precision Components for the Aircraft, Military, Medical, Aerospace and Laser Industries.
Primary
San Jose
CA
USA
ISO 9001:2008
Design, Development and Provision of Total Solutions, Including Semiconductor Components, IP, and Development Tools.
Altera Corporation (M) Sdn. Bhd.
Secondary
Bayan Lepas/Penang
Malaysia
ISO 9001:2008
Design, Development and Provision of Total Solutions, Including Semiconductor Components, IP, and Development Tools.
American Bio Medica Corporation
Primary
Kinderhook
NY
USA
ISO 13485/CMDCAS
The design/development, manufacture and distribution of in-vitro diagnostic test kits and related equipment utilizing lateral flow immunoassay technology
used in the rapid screening test of drugs of abuse, infectious diseases and other analytes.
American Bio Medica Corporation
Secondary
Logan Township
NJ
USA
ISO 13485/CMDCAS
The design/development, manufacture and distribution of in-vitro diagnostic test kits and related equipment utilizing lateral flow immunoassay technology
used in the rapid screening test of drugs of abuse, infectious diseases and other analytes.
American Durafilm
Primary
Holliston
MA
USA
ISO 9001:2008
Manufacture of seamless polyimide tubing and assemblies for the Medical, Aerospace, and Electronics Industries
American Durafilm
Secondary
Cornelius
NC
USA
ISO 9001:2008
Manufacture of seamless polyimide tubing and assemblies for the Medical, Aerospace, and Electronics Industries
American Tools, Inc.
Single
Bayamon
PR
Puerto Rico
ISO 9001:2008
Fabrication of Sheet Metal Products
AMETEK
Single
Pittsburgh
PA
USA
ISO 9001:2008
The design, manufacture and service of gas and liquid process instruments and instrument systems for industrial and laboratory applications.
COMPANY
Altera Corporation
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Scope
The design, manufacture, and distribution of in-vitro diagnostic medical devices used to screen for the presence of drugs of abuse, cancer markers,
cardiac markers and transmissible agents; and for fertility testing and pregnancy testing.
The manufacture and distribution of orthotic devices
The Design, Manufacture and Distribution of Specialty Operating Tables and Positioning Accessories for the Operating Room.
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
Ametek Power and Data Systems
Secondary
Harleysville
PA
USA
AS 9100 - C
The design and manufacture of aerospace instrumentation to specifications agreed upon with other Ametek organizations and our customers
Ametek Power and Data Systems
Primary
Binghamton
NY
USA
AS 9100 - C
The design and manufacture of aerospace instrumentation to specifications agreed upon with other Ametek organizations and our customers.
Ametek Process Instruments
Single
Newark
DE
USA
ISO 9001:2008
The design, manufacture and service of gas and liquid process instruments and instument systems for industrial and laboratory applications.
Amnisure International LLC.
Single
Boston
MA
USA
ISO 13485/CMDCAS
Amphenol (Changzhou) Advanced Connector
Secondary
Jiangsu
China
ISO 9001:2008
The design and manufacturing of backplane systems and high speed, high density connector components, cables, thermocouple components and
assemblies
Amphenol (Changzhou) Advanced Connector
Secondary
Jiangsu
China
ISO 14001:2004
The manufacture of backplane, connector, cables, thermocouple components and electromechanical systems.
Amphenol (Changzhou) Connector System
Secondary
Jiangsu
China
ISO 9001:2008
The design and manufacture of backplanes.
Single
Nashua
USA
AS 9100 - C
Amphenol de Mexico S.A. de C.V.
Secondary
El Dorado
Mexico
ISO 9001:2008
The manufacturing of backplane systems and high speed, high density connector components and assemblies.
Amphenol InterCon Systems
Secondary
Harrisburg
PA
USA
ISO 9001:2008
Design and manufacturing of interconnection devices and High Speed Cables.
Amphenol Printed Circuit Board Technolog
Single
Nogales, Sonora
Mexico
Mexico
AS 9100 - C
Manufacture of high technology backplanes, daughter cards, flex and rigid flex printed circuits and value added assembly services for aerospace, military
and commercial applications.
Amphenol Printed Circuits
Single
Nashua
NH
USA
AS 9100 - C
Design and manufacture of high technology backplanes, daughter cards, flex, and rigid flex printed circuits and value added assembly services for
aerospace, military and commercial applications.
Secondary
Winston-Salem
NC
USA
ISO 14001:2004
COMPANY
Amphenol Backplane Systems
Amphenol TCS
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
NH
Scope
The design, manufacture, and distribution of In Vitro Diagnosis Testing for Rupture of Fetal Membrane and Time to Delivery.
The manufacture of electrical connectors, backplanes and high performance electrical interconnect systems
The manufacture of connector components, metal stampings, conventional and reel-to-reel insert molded products for the communications, electronic and
automotive industries.
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
Amphenol TCS
Secondary
Nashua
NH
USA
ISO 14001:2004
The manufacture of backplane and connector systems.
Amphenol TCS
Secondary
Winston Salem
NC
USA
ISO 9001:2008
The manufacturing of backplane systems and high speed, high density connector components and assemblies.
Amphenol TCS
Primary
Nashua
NH
USA
ISO 14001:2004
The design and manufacturing of backplane systems and high speed, high density connector components and assemblies
Amphenol TCS - CMG
Primary
Nashua
NH
USA
ISO 9001:2008
The design and manufacturing of backplane systems and high speed, high density connectors, components and assemblies.
Amphenol TCS (Malaysia) Sdn. Bhd.
Secondary
Penang
Malaysia
ISO 9001:2008
The design and manufacturing of backplane systems and high speed, high density connector components and assemblies.
Amphenol TCS (Malaysia) Sdn. Bhd.
Secondary
S.P.T Penang
Malaysia
ISO 14001:2004
The design and manufacturing of backplane systems and high speed, high density connector components and assemblies
Amphenol TCS de Mexico S.A. de C.V.
Secondary
El Dorado
Mexico
ISO 14001:2004
The design and manufacture of backplane systems and high speed, high density connector components and assemblies.
Amulet Technologies, LLC
Single
Campbell
CA
USA
ISO 9001:2008
The design of high performance embedded Graphical User Interface (GUI) solutions for microcontroller based products.
Amulet Technologies, LLC
Single
Campbell
CA
USA
ISO 14001:2004
The design of high performance embedded Graphical User Interface (GUI) solutions for microcontroller based products.
Andromeda Systems Incorporated
Primary
Orange Park
FL
USA
ISO 9001:2008
Design and Service Provider of Engineering, Maintenance and Logistics, Information Technology, Program Management, Acquisition Support and
Financial Services to include any other Associated Services to Commercial and Government Enterprises.
Andromeda Systems Incorporated
Secondary
Virginia Beach
VA
USA
ISO 9001:2008
Service Provider of Engineering, Maintenance and Logistics, Information Technology, Program Management, Acquisition Support and Financial Services
to include any other Associated Services to Commercial and Government Enterprises.
AOTI Ltd
Single
Co. Galway
Ireland
ISO 13485/CMDCAS
Applied Ceramics, Inc
Single
Fremont
USA
ISO 9001:2008
COMPANY
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
CA
Scope
The Manufacture and Distribution of Oxygen Therapy Systems.
The manufacture and service of ceramic precision components for the high tech industries.
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
Applied Circuit Technology Inc.
Single
Richardson
TX
USA
EN ISO 13485:2012
ISO 13485 Scope: The Layout, Manufacture and Final Test of Printed Circuit Boards and Electromechanical Assemblies used for Medical Devices.9K
Scope: The Layout, Manufacture and Final Test of Printed Circuit Boards and Electromechanical Assemblies.
Applied Science, Inc
Single
Grass Valley
CA
USA
EN ISO 13485:2012
The Manufacture and Distribution of Electronic Blood Collection and Mixing Systems.
APS Materials Inc
Single
Co. Waterford
Ireland
EN ISO 13485:2012
The manufacture and application of Thermal Spray Coating Solutions for the Bio-Medical and other industries.ISO 9k:The manufacture and application of
Thermal Spray Coating Solutions for the Bio-Medical and other industries
AQF Limited
Single
Co. Meath
Ireland
EN ISO 13485:2012
MD Scope: The manufacture and distribution of foam components and products for the medical device industry.ISO9K Scope: The manufacture of flexible
foam products and packaging material.
ARC Technology Solutions, LLC
Single
Nashua
USA
ISO 9001:2008
Arcadyan Technology Corp.
Single
Hsinchu
Taiwan, R.O.C.
TL 9000 R5.0/5.0
ARTESYN TECHNOLOGIES ASIA-PACIFIC
LIMITE
Secondary
Guangdong
China
ECCB HSPM
Manufacture of AC/DC and DC/DC power supplies. Manufacture of embedded computing products.
ARTESYN TECHNOLOGIES ASIA-PACIFIC
LIMITE
Primary
Hong Kong
China
ECCB HSPM
Manufacture of AC/DC and DC/DC power supplies. Manufacture of embedded computing products.
Associates of Cape Cod, Inc.
Single
East Falmouth
USA
ISO 13485/CMDCAS
Atotech Taiwan Limited, Advanced Tech Ct
Single
Taoyuan County
Taiwan, R.O.C.
ECCB HSPM
Atotech Taiwan Ltd, Materials Science La
Single
Taoyuan County
Taiwan, R.O.C.
IECQ ITL
Micro resistance reliability test, mechanical and materials test for electronics, general metal finishing and semiconductor industries, including test for
Measurement of Coating Thickness by X-Ray FluorescenceSpectrometry (ASTM B568), Peel Strength Test of Copper Film (IPC TM-650 2.4.8 C), and
Interconnect Stress Test (IST, IPC TM 650 2.6.26).
COMPANY
NH
MA
Scope
Provision of electrical, software and test engineering and manufacturing services for the electronic industry.
ISO 9001:2008 Scope - Design and Distribution of Wireless Telecommunication Products.TL9000-H Scope: Design and Distribution of Wireless
Telecommunication Products for the Following Product Category: 6.2.4 Digital Data Service Units.
The Design, Manufacture and Distribution of Limulus Amebocyte Lysate (LAL) Reagents (including In-Vitro Diagnostic Medical Devices for the Analysis of
(1-->3)-ß-D-Glucan to Support the Diagnosis of Invasive Fungal Disease) andRelated Materials and Equipment; Contract Testing for Endotoxin and
Glucan.
This IECQ HSPM Independent Testing Laboratory (ITL) certificate of approval is applicable to all electronic components and related materials and
processes for the Chemicals analysis for electronics, general metal finishing and semiconductorindustries.The IECQ HSPM assessment is conducted in
accordance with related IECQ QC 080000 Specification and the IECQ Rules of Procedure IECQ 03-5.
Atotech Taiwan Ltd., Advanced Tech Cente
Secondary
Kaohsiung City
Taiwan, R.O.C.
IECQ ITL
Micro resistance reliability test, mechanical and materials test for electronics, general metal finishing and semiconductor industries, including test for
Measurement of Coating Thickness by X-Ray Spectrometry (ISO3497), Coefficiency of friction testing (PSA C100054), Test for Simultaneous Thickness
and Electrode Potential Determination of Individual Layers in Multilayer Nickel Deposit (STEP Test, ASTM B 764), Standard Practice forOperating Salt
Spray (Fog) Apparatus (NSS Test, ASTM B117), Test for Copper-Accelerated Acetic Acid-Salt Spray (Fog) Testing (CASS Test, ASTM B368), and
Kesternish test (ASTM D1193).
Atotech Taiwan Ltd., Advanced Technology
Secondary
Kaohsiung City
Taiwan, R.O.C.
IECQ ITL
This IECQ HSPM Independent Testing Laboratory (ITL) certificate of approval is applicable to all electronic components and related materials and
processes for the Chemicals analysis for electronics, general metal finishing and semiconductorindustries.The IECQ HSPM assessment is conducted in
accordance with related IECQ QC 080000 Specification and the IECQ Rules of Procedure IECQ 03-5.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
Scope
Austin Energy
Secondary
Austin
TX
USA
ISO 9001:2008
The provision of utility customer services including receiving customer requests, responding to customer requests, billing customers, processing customer
payments, and managing customer accounts.
Austin Energy
Secondary
Austin
TX
USA
ISO 9001:2008
The provision of utility customer services including receiving customer requests, responding to customer requests, billing customers, processing customer
payments, and managing customer accounts.
Austin Energy
Primary
Austin
TX
USA
ISO 9001:2008
The provision of utility customer services including receiving customer requests, responding to customer requests, billing customers, processing customer
payments, and managing customer accounts.
Austin Energy
Secondary
Austin
TX
USA
ISO 9001:2008
The provision of utility customer services including receiving customer requests, responding to customer requests, billing customers, processing customer
payments, and managing customer
Austin Energy
Secondary
Austin
TX
USA
ISO 9001:2008
The provision of utility customer services including receiving customer requests, responding to customer requests, billing customers, processing customer
payments, and managing customer accounts.
Austin Energy Power Supply
Secondary
Austin
TX
USA
ISO 9001:2008
The processes for planning, procuring, producing and marketing electricity to retail customers, ERCOT and wholesale markets.
Austin Energy Power Supply
Secondary
Del Valle
TX
USA
ISO 9001:2008
The processes for planning, procuring, producing and marketing electricity to retail customers, ERCOT and wholesale markets.
Austin Energy Power Supply
Primary
Austin
TX
USA
ISO 9001:2008
The processes for planning, procuring, producing and marketing electricity to retail customers, ERCOT and wholesale markets.
Austin Energy Power Supply
Secondary
Austin
TX
USA
ISO 9001:2008
The processes for planning, procuring, producing and marketing electricity to retail customers, ERCOT and wholesale markets.
Automated Circuit Design
Single
Richardson
TX
USA
AS 9100 - C
Avenue Mould Solutions
Single
Co Sligo
Ireland
ISO 9001:2008
Avenue Mould Solutions Ltd
Single
Co. Sligo
Ireland
EN ISO 13485:2012
Primary
Huntsville
USA
ISO 9001:2008
COMPANY
Avocent Corp.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
AL
The Layout and Procurement of Printed Circuit Boards, Manufacture and Final Test of Printed Circuit Board Assemblies, and Electromechanical
Assemblies for Medical, Aerospace and Commercial Devices.
The design, manufacture, modification and repair or injection moulds
The contract manufacture of injection moulded medical device components and the provision of validation services.
The Design, Development, Manufacture, Marketing, Sale and Support of Electronic Devices for Computer Interface Products.
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
Avocent Corp.
Secondary
Sunrise
FL
USA
ISO 9001:2008
Engineering software and customer support.
Avocent Corp.
Secondary
Shannon Free Zone,
Shannon Co.
Ireland
ISO 9001:2008
The Design, Development, Manufacture, Marketing, Sale and Support of Electronic devices for Computer Interface Products.
Azure MicroDynamics, Inc.
Single
Lake Forest
CA
USA
EN ISO 13485:2012
B&G Precision Inc.
Single
Fremont
CA
USA
AS 9100 - C
B&G Precision Inc.
Single
Fremont
CA
USA
EN ISO 13485:2012
MD Scope: Contract Machining, Manufacture, and Assembly of Medical Device Components and Non-Active Sub-Assemblies.ISO9K Scope: The
Manufacture of Critical Components and Assemblies for the Medical and Aerospace Industries.
B. Braun Hospicare Limited
Single
County Sligo
Ireland
EN ISO 13485:2012
The design and manufacture of wound care products.
B. Braun Medical Ltd.
Single
Dublin 12
Ireland
ISO 9001:2008
B. L. Industria Otica Ltda.
Single
Brazil
Brazil
EN ISO 13485:2012
B3CG Interconnect
Single
St. Eustache - Quebec
Canada
ECCB HSPM
Secondary
Fort Wayne
IN
USA
ECCB ECMP (TS-62239)
Designs, Manufactures, Services and Tests Various Products for Avionics, Aerospace, Space, Internal Systems, Military Products & Systems, and Power
Systems.
Primary
Endicott
NY
USA
ECCB ECMP (TS-62239)
Designs, Manufactures, Services and Tests Various Products for Avionics, Aerospace, Space, Internal Systems, Military Products & Systems, and Power
Systems.
Barksdale, Inc.
Single
Los Angeles
CA
USA
ISO 9001:2008
Bausch & Lomb - Iom Spa
Single
Monza Brianza
Italy
EN ISO 13485:2012
COMPANY
BAE Systems
BAE Systems Controls
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Scope
(ISO 13485 Scope)The manufacturing and distribution of medical devices for use in orthodontics. Contract manufacturing of non-active metal and plastic
components and subassemblies for use in medical devices.(ISO 9001 Scope) The contract manufacturing of metal and plastic components and subassemblies for use in the medical device industry.
Contract machining, manufacturing and assembly of components and sub-assemblies for the aviation, space and defense industries.
The Sales, Marketing, Distribution and after-sales support of pharmaceutical products, medical devices and equipment.
The manufacture and distribution of contact lenses.
Manufacturing of HSF cables, wire harnesses and electromechanical assemblies for industrial, medical and communications applications.
The design and manufacture of hydraulic valves, temperature switches, pressure switches, transducers, and level switches
MD and ISO9K Scope: The manufacture and distribution of contact lens solutions.
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
Scope
Bausch & Lomb Hastings
Secondary
Hastings
East Susse
United Kingdom
ISO 13485/CMDCAS
CM & MD: The Design and Development, Manufacture, and Distribution of Contact Lenses, Contact Lens Care Products and Accessories for Rinsing,
Cleaning, Lubricating, Rewetting, and Storage of Contact Lenses. The Manufacture of intraocular lensmaterials & IOL buttons, and Over the Counter Eye
Drop Products. Contract Irradiation Sterilisation in accordance with EN ISO 11137-1:2006.ISO9K: The design and development, manufacture, distribution
of contact lenses, contact lens care products and accessories for rinsing, cleaning and storage of contact lenses, and over the counter opthalmic products.
Bausch & Lomb Incorporated
Secondary
Rancho Cucamonga
CA
USA
ISO 13485/CMDCAS
The Design and Development, Manufacture, and Distribution of Intraocular Lenses.
Bausch & Lomb Incorporated
Secondary
Irvine
CA
USA
ISO 13485/CMDCAS
The Design and Development, Manufacture, and Distribution of Intraocular Lenses.
Bausch & Lomb Incorporated
Secondary
Rancho Cucamonga
CA
USA
ISO 13485/CMDCAS
The Design and Development, Manufacture, and Distribution of Intraocular Lenses.
Bausch & Lomb Incorporated
Secondary
Rancho Cucamonga
CA
USA
ISO 13485/CMDCAS
The Design and Development, Manufacture, and Distribution of Intraocular Lenses.
COMPANY
Bausch & Lomb Incorporated
Primary
Rochester
NY
USA
ISO 13485/CMDCAS
CM & MD: The Design and Development, Manufacture, and Distribution of Contact Lenses, Contact Lens Care Products and Accessories for Rinsing,
Cleaning, Lubricating, Rewetting, and Storage of Contact Lenses. The Manufacture of intraocular, gaspermeable and soft lens materials, and Over the
Counter Eye Drop Products. Contract Irradiation Sterilisation in accordance with EN ISO 11137-1:2006.ISO9K: The design and development, manufacture,
distribution of contact lens materials, contact lenses, contact lens care products and accessories for rinsing, cleaning and storage of contact lenses, and
over the counter opthalmic products.
Bausch & Lomb Incorporated
Primary
Rochester
NY
USA
ISO 13485/CMDCAS
The Design and Development, Manufacture, and Distribution of Intraocular Lenses.
ISO 13485/CMDCAS
CM & MD: The Design and Development, Manufacture, and Distribution of Contact Lenses, Contact Lens Care Products and Accessories for Rinsing,
Cleaning, Lubricating, Rewetting, and Storage of Contact Lenses. The Manufacture of intraocular lensmaterials & IOL buttons, and Over the Counter Eye
Drop Products. Contract Irradiation Sterilisation in accordance with EN ISO 11137-1:2006.ISO9K: The design and development, manufacture, distribution
of contact lenses, contact lens care products and accessories for rinsing, cleaning and storage of contact lenses, and over the counter opthalmic products.
Bausch & Lomb Incorporated
Secondary
Greenville
SC
USA
Bausch & Lomb Incorporated
Secondary
Greenville
SC
USA
ISO 13485/CMDCAS
CM & MD: The Design and Development, Manufacture, and Distribution of Contact Lenses, Contact Lens Care Products and Accessories for Rinsing,
Cleaning, Lubricating, Rewetting, and Storage of Contact Lenses. The Manufacture of intraocular lensmaterials & IOL buttons, and Over the Counter Eye
Drop Products. Contract Irradiation Sterilisation in accordance with EN ISO 11137-1:2006.ISO9K: The design and development, manufacture, distribution
of contact lenses, contact lens care products and accessories for rinsing, cleaning and storage of contact lenses, and over the counter opthalmic products.
Bausch & Lomb Incorporated
Secondary
Wilmington
MA
USA
ISO 13485/CMDCAS
CM & MD: The Design and Development, Manufacture, and Distribution of Contact Lenses, Contact Lens Care Products and Accessories for Rinsing,
Cleaning, Lubricating, Rewetting, and Storage of Contact Lenses. The Manufacture of intraocular lensmaterials & IOL buttons, and Over the Counter Eye
Drop Products. Contract Irradiation Sterilisation in accordance with EN ISO 11137-1:2006.ISO9K: The design and development, manufacture, distribution
of contact lenses, contact lens care products and accessories for rinsing, cleaning and storage of contact lenses, and over the counter opthalmic products.
ISO 13485/CMDCAS
CM & MD: The Design and Development, Manufacture, and Distribution of Contact Lenses, Contact Lens Care Products and Accessories for Rinsing,
Cleaning, Lubricating, Rewetting, and Storage of Contact Lenses. The Manufacture of intraocular lensmaterials & IOL buttons, and Over the Counter Eye
Drop Products. Contract Irradiation Sterilisation in accordance with EN ISO 11137-1:2006.ISO9K: The design and development, manufacture, distribution
of contact lenses, contact lens care products and accessories for rinsing, cleaning and storage of contact lenses, and over the counter opthalmic products.
Bausch & Lomb Incorporated
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Secondary
Clearwater
FL
USA
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
COMPANY
Profile
Type
CITY
STATE
Scheme
Scope
Ireland
ISO 13485/CMDCAS
CM & MD: The Design and Development, Manufacture, and Distribution of Contact Lenses, Contact Lens Care Products and Accessories for Rinsing,
Cleaning, Lubricating, Rewetting, and Storage of Contact Lenses. The Manufacture of intraocular lensmaterials & IOL buttons, and Over the Counter Eye
Drop Products. Contract Irradiation Sterilisation in accordance with EN ISO 11137-1:2006.ISO9K: The design and development, manufacture, distribution
of contact lenses, contact lens care products and accessories for rinsing, cleaning and storage of contact lenses, and over the counter opthalmic products.
Netherlands
EN ISO 13485:2012
The logistics and distribution of contact lens products, contact lens care products and the managment of postponement and re-packaging activities.
Ireland
ISO 9001:2008
Bausch & Lomb Ireland
Secondary
Bausch + Lomb OPS BV
Single
Baxter Healtcare Ltd
Single
Co Dublin
Bayer HealthCare, LLC
Single
Milpitas
CA
USA
ISO 13485/CMDCAS
Baystate Metal Solutions Inc.
Single
Springfield
MA
USA
ISO 9001:2008
BD Caribe Ltd.
Single
Juncos
PR
Puerto Rico
EN ISO 13485:2012
Primary
Research Triangle Park
NC
USA
IECQ ITL
BD Medical
Single
Franklin
WI
USA
EN ISO 13485:2012
The manufacture, packaging and distribution of pre-filled sterile flush syringes
BD Medical - Diabetes Care
Single
Holdrege
NE
USA
EN ISO 13485:2012
The manufacture, packaging, sterilisation and contract sterilisation of drug delivery devices including syringes and pen needles, device components for
assembly at other BD locations, and alcohol swabs.
BD Medical Surgical
Single
Columbus
NE
USA
EN ISO 13485:2012
ISO13485 & 9001:2008: The manufacture of sterile and non-sterile hypodermic needles, syringes, and components. The manufacture of saline and
heparin pre-filled syringes for irrigation. Irradiation Sterilization in Accordance with EN ISO 11137:2006 .Moist heat sterilization in accordance with EN ISO
17665-1:2006.
BD Medical, Pharmaceutical Systems
Single
Columbus
NE
USA
EN ISO 13485:2012
The Manufacture of Pre-fillable, Drug Delivery Components. In-house Ethylene Oxide Sterilization in Accordance with ISO 11135:2007.
BE Peterson Inc.
Single
Avon
MA
USA
ISO 9001:2008
Design and Manufacture of Heavy-Gauge Metal Parts, Equipment and ASME Code Tanks & Filtration Vessels for Power and Utilities, Medical,
Chemical/Environmental/Filtration, and Other Industrial Applications
Secondary
Co Galway
Ireland
ISO 13485:2003
13485 Scope: The design and development, manufacture, distribution and customer support of clinical chemistry, haematology, heterogenous
immunoassay and flow cytometry in vitro diagnostic devices.9001 Scope: The manufacture and repair of centrifuge rotors.
BD Corporate Preclinical Development
Beckman Coulter (Ireland) Inc.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Waterford
Country
The sale, distribution and technical servicing of healthcare products; the compounding sale and distribution of compounded products and the provision and
support of renal care services
The design, manufacture, and distribution of sterile intrafallopian tube implants and delivery systems.
Design and Manufacture of Precision Sheet Metal and Assembly of Products.
The manufacture of sterile and non-sterile, single use devices including specialty needles (epidural, spinal, biopsy), safety needle, chest drain valve,
bladder drain catheter, catheter adapter and accessories, micro-collection, specimen collection,blood transfer and lancets for the worldwide heathcare
community.
This IECQ ITL certification is applicable to all electronic components and related materials and processes for the: Biocompatibility, saftey and Toxicalogical
testing for a wide array of medical supplies, devices, laboratory equipment and diagnosticproducts.
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
Beckman Coulter Biomedical GmbH
Primary
Beckman Coulter Biomedical GmbH
COMPANY
Beckman Coulter Eurocenter S.A.
Beckman Coulter Genomics
STATE
Country
Scheme
Muenchen
Germany
ISO 13485:2003
Design/Development, Manufacture, Supply and Customer Support of Laboratory Automation Systems
Secondary
Muenchen
Germany
I.S.EN ISO13485:2012
Design/Development, Manufacture, Supply and Customer Support of Laboratory Automation Systems
Primary
Nyon 1
Switzerland
ISO 9001:2008
The sale, installation and service of products for biomedical testing and the central administration of European sales and service orders including
management of the distribution processes.
Single
Danvers
USA
ISO 9001:2008
Genomic services and the production, contract manufacture and distribution of nucleic acid purification products.
Switzerland
ISO 9001:2008
The production of technical blow moulding products
MA
Scope
Beckman Coulter International S.A.
Primary
Beckman Coulter Ireland Inc.
Primary
Co. Clare
Ireland
ISO 13485:2003
The design and development, manufacture, distribution and customer support of clinical chemistry, haematology, heterogenous immunoassay and flow
cytometry in vitro diagnostic devices.ISO 9k -
Beckman Coulter Ireland Inc.
Secondary
Co. Clare
Ireland
ISO 14001:2004
The design, development, manufacture, supply and customer support of clinical chemistry and heterogenous immunoassay in-vitro diagnostic devices
Beckman Coulter Molecular Diagnostics
Primary
Brea
CA
USA
ISO 13485/CMDCAS
The design, development and manufacture of in-vitro diagnostics systems, including hardware, software, kits, reagents, and calibrators used in the
monitoring and management of diseases.
Beckman Coulter Molecular Diagnostics
Secondary
Danvers
MA
USA
ISO 13485/CMDCAS
The design, development and manufacture of in-vitro diagnostics systems, including hardware, software, kits, reagents, and calibrators used in the
monitoring and management of diseases.
Beckman Coulter, Inc.
Secondary
Irving
TX
USA
EN ISO 13485:2012
The installation and service of biomedical testing products and in-vitro diagnostics.
Beckman Coulter, Inc.
Secondary
Indianapolis
IN
USA
EN ISO 13485:2012
The installation and service of biomedical testing products and in-vitro diagnostics.
Beckman Coulter, Inc.
Secondary
Indianapolis
IN
USA
I.S.EN ISO13485:2012
ISO 13485 Scope: The Design and Development of Automated Systems for the Clinical Marketplace and the Manufacture of Components.ISO 9001:2008
Scope: The Design, Development, Manufacture and Custom Integration of Automated Systems and Consumables for Biomedical Research and Testing.
ISO 13485/CMDCAS
The design, development, manufacture, distribution and post sales support of in-vitro diagnostic systems (hardware, software, reagents, calibrators,
controls) and remanufacture of hardware used in the diagnosis and/or managment of cancer,prenatal screening, immune disease and autoimmune status,
inflammatory disease, bone metabolism disorders, anemia, diabetes, cardiac disease, endocrine disorders, blood analytes, transmissable agents, sexually
transmissable agents, fertility andpregnancy testing, and for therapeutic drug monitoring.
Beckman Coulter, Inc.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Secondary
Chaska
MN
USA
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
COMPANY
Beckman Coulter, Inc.
Profile
Type
CITY
STATE
Country
Scheme
Primary
Brea
CA
USA
ISO 13485/CMDCAS
The design, manufacture and distribution of in-vitro diagnostic reagents and test kits used in donor screening for blood type and infectious diseases.
Scope
Beckman Coulter, Inc.
Secondary
Chaska
MN
USA
ISO 13485/CMDCAS
The design, development, manufacture, distribution and post sales support of in-vitro diagnostic systems (hardware, software, reagents, calibrators,
controls) and remanufacture of hardware used in the diagnosis and/or managment of cancer,prenatal screening, immune disease and autoimmune status,
inflammatory disease, bone metabolism disorders, anemia, diabetes, cardiac disease, endocrine disorders, blood analytes, transmissable agents, sexually
transmissable agents, fertility andpregnancy testing, and for therapeutic drug monitoring.
Beckman Coulter, Inc.
Primary
Brea
CA
USA
EN ISO 13485:2012
The design, development, manufacture, sale, distribution, installation and service of products for biomedicaltesting.
Beckman Coulter, Inc.
Single
Carlsbad
CA
USA
EN ISO 13485:2012
MD: The Manufacture of In Vitro Diagnostic Reagents and Consumables used for the Determination of a Variety of Analytes of Clinical Interest including
Assays for Speciality, Cardiac, Drugs of Abuse, Thyroids, Proteins, Therapeutic Drugs and Lipids.ISO9K: The manufacture of Life Science reagents and
buffers used in capiliary electrophoresis for DNA/RNA research, gene expression research, protein purity applications, carbohydrate applications, and iso
electric focusing applications.
Beckman Coulter, Inc.
Primary
Brea
CA
USA
ISO 13485/CMDCAS
The design, development, manufacture, service and distribution of automated sample processing systems and in vitro diagnostics systems, including
hardware, software, kits, reagents, calibrators and controls used in the diagnosis of diseasesand for therapeutic drug monitoring.
Beckman Coulter, Inc.
Primary
Brea
CA
USA
ISO 13485/CMDCAS
The design, development, manufacture, service and distribution of haematology and cytology analyzers, reagents, and quality controls used in flow
cytometry and blood component determinations for patient management and monitoring of disease statesimmunity and haematological disorders
Beckman Coulter, Inc.
Secondary
Florence
KY
USA
EN ISO 13485:2012
The design, development, manufacture, repair and remanufacture of hematology, cytometry systems, reagents and controls used in cellular analysis,
patient management and monitoring of disease states,immunity and haematological disorders.
Beckman Coulter, Inc.
Primary
Brea
CA
USA
ISO 13485/CMDCAS
The design, development, manufacture and distribution of in-vitro diagnostic medical devices for detection of fecal occult blood, pregnancy, viral and
bacterial infections.
Beckman Coulter, Inc.
Secondary
Brea
CA
USA
EN ISO 13485:2012
The design and development of automated systems for the clinical marketplace and the manufacture of components.
Beckman Coulter, Inc.
Secondary
Indianapolis
IN
USA
EN ISO 13485:2012
The installation and service of biomedical testing products and in-vitro diagnostics.
Beckman Coulter, Inc.
Secondary
Irving
TX
USA
ISO 13485/CMDCAS
The design, manufacture and distribution of in-vitro diagnostic reagents and test kits used in the screening of blood for typing, and the detection of
infectious diseases.
Beckman Coulter, Inc.
Secondary
Chaska
MN
USA
ISO 13485/CMDCAS
The design, development, manufacture, distribution and post sales support of in-vitro diagnostic systems (hardware, software, reagents, calibrators,
controls) and remanufacture of hardware used in the diagnosis and/or managment of cancer,prenatal screening, immune disease and autoimmune status,
inflammatory disease, bone metabolism disorders, anemia, diabetes, cardiac disease, endocrine disorders, blood analytes, transmissable agents, sexually
transmissable agents, fertility andpregnancy testing, and for therapeutic drug monitoring.
ISO 13485/CMDCAS
The design, development, manufacture, distribution and post sales support of in-vitro diagnostic systems (hardware, software, reagents, calibrators,
controls) and remanufacture of hardware used in the diagnosis and/or managment of cancer,prenatal screening, immune disease and autoimmune status,
inflammatory disease, bone metabolism disorders, anemia, diabetes, cardiac disease, endocrine disorders, blood analytes, transmissable agents, sexually
transmissable agents, fertility andpregnancy testing, and for therapeutic drug monitoring.
Beckman Coulter, Inc.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Primary
Chaska
MN
USA
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
Beckman Coulter, Inc.
Primary
Brea
CA
USA
EN ISO 13485:2012
The storage, distribution and transportation of biomedical testing products including in-vitro diagnostics.
Beckman Coulter, Inc.
Secondary
Chaska
MN
USA
EN ISO 13485:2012
The installation and service of biomedical testing products and in-vitro diagnostics.
Beckman Coulter, Inc.
Primary
Brea
CA
USA
EN ISO 13485:2012
The installation and service of biomedical testing products and in-vitro diagnostics.
Beckman Coulter, Inc.
Primary
Brea
CA
USA
ISO 13485/CMDCAS
The design, development, manufacture, service and distribution, of in vitro diagnostic systems, including hardware, software, kits, reagents, calibrators and
controls used in the diagnosis and/or management of cancer, prenatal screening, Immunedisease and autoimmune status, inflammatory disease, bone
metabolism disorders, anemia, diabetes, cardiac disease, endocrine disorders, blood analytes, transmissable agents, fertility and pregnancy testing, and
for therapeutic drug monitoring.
Beckman Coulter, Inc.
Primary
Brea
CA
USA
ISO 9001:2008
The design, development, manufacture, sale, distribution, installation and service of products for biomedicaltesting.
Becton Dickinson and Company
Secondary
Co. Louth
Ireland
ISO 14001:2004
The manufacture of blood lancets, sterile and non sterile hypodermic needles and syringes and needle components for syringes
Becton, Dickinson and Company
Primary
Franklin Lakes
NJ
USA
ISO 13485/CMDCAS
MD/CM Scope: The Design, Manufacture and Distribution of Sterile and Non-Sterile Needles, Syringes, Pre-Filled Syringes, Needless Access Devices,
Catheters and Catheter Accessories forVascular Access, Drainage, Infusion and Epidural use, Anesthesia, Radiology and Biopsy Kits, Trays and
Accessories, and Closed System Transfer Devices. (ISO9K ending only: Specialty Plastic Containers for the Collection and Transport of
HealthcareWaste.)
Becton, Dickinson and Company
Single
Canaan
CT
USA
EN ISO 13485:2012
The Manufacture of Sterile and Non-Sterile, High and Low Volume Hypodermic Syringes, Syringe Components and IV Cannula Products.
Becton, Dickinson and Company
Single
Co. Dublin
Ireland
EN ISO 13485:2012
The Manufacture, Packaging and Sterilization of Insulin Delivery Systems and Blood Lancing Accessories.
Becton, Dickinson and Company (BD)
Single
Sumter
SC
USA
EN ISO 13485:2012
The manufacture, molding and irradation sterilization of disposable medical devices for use in blood collection and laboratory services.
Becton, Dickinson and Company (BD)
Single
Broken Bow
NE
USA
EN ISO 13485:2012
The molding and manufacture of sterile and non-sterile blood collection devices, urine collection devices, cell preparation tubes, anaerobic specimen
collection devices and needle holders. The provision of intra-company label printing and irradiationsterilization services in accordance with ISO 11137.
Becton, Dickinson and Company (BD)
Single
Franklin Lakes
NJ
USA
ISO 13485/CMDCAS
The Design and Development, Manufacture and Distribution of preanalytical products including sterile and non-sterile blood / urine collection devices,
sterile cell preparation devices, anaerobic specimen collectiondevices, venting unit sub-assemblies, blood collection needles, administration sets,
microcollection devices and lancets.
Becton, Dickinson and Company Limited
Single
Co. Dublin
Ireland
ISO 13485/CMDCAS
The manufacture and distribution of medical devices for drug transfer, medical components, non-active medical devices and diagnostic products.
COMPANY
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Scope
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
Becton, Dickinson and Company Limited
Single
Co. Louth
Bern Optics, Inc
Single
Westfield
Bijur Delimon International
Single
Kinston
Bio Medical Research, Ltd
Single
Co. Galway
BioCheck, Inc.
Single
Foster City
Biohelix Corporation
Single
Beverly
Biolab Equipment Ltd.
Single
Burlington, Ontario
Biomedical Structures LLC
Secondary
Warwick
Biomedical Structures LLC
Primary
Warwick
Single
COMPANY
Biomnis Irealand (Logistics Division)
BioTek Instruments GmbH
BioTek Instruments, Inc
Bluegrass Supply Chain Services
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
STATE
Country
Scheme
Scope
Ireland
EN ISO 13485:2012
The manufacture and distribution of blood lancets, insulin delivery system accessories, sterile and non-sterile hypodermic needles and syringes, prefilled
syringes and components for syringes.
MA
USA
EN ISO 13485:2012
The manufacture and distribution of optical components and assemblies for medical device equipment and instrument applications.
NC
USA
ISO 9001:2008
Ireland
ISO 13485/CMDCAS
CA
USA
ISO 13485:2003
The design, manufacture and distribution of ELISA test kits for Tumor markers, cardiac markers, hormone, fertility, TORCH, infectious disease, other
analytes (IgE and Ferritin) and contract development and manufacturing.
MA
USA
ISO 13485:2003
The Design and Development, and Manufacture of Helicase Dependent Amplification (HDA) In-Vitro Diagnostic Components.
Canada
ISO 13485/CMDCAS
RI
USA
ISO 13485:2003
Design, Development, and Manufacture of textile and composite materials for the biomedical / biosurgical / tissue engineering markets. Biomedical
Structures is a contract design, development, and manufacturing firm.
RI
USA
ISO 13485:2003
Design, Development, and Manufacture of textile and composite materials for the biomedical / biosurgical / tissue engineering markets. Biomedical
Structures is a contract design, development, and manufacturing firm.
Dublin 18
Ireland
ISO 9001:2008
Transportation of pathological specimens to Healthcare Settings
Secondary
Bad Friedrichshall
Germany
EN ISO 13485:2012
ISO13485 : The Design, Manufacture, Distribution, Service and Installation of in-vitro diagnostic Microplate Readers, Washers, Dispensers, Stackers,
Pipetting Work Stations and Accessories.
Primary
Winooski
VT
USA
EN ISO 13485:2012
ISO 13485 Scope: The Design, Manufacture, Distribution, Service and Installation of in-vitro diagnostic Microplate Readers, Washers, Dispensers,
Stackers, Pipetting Work Stations and Accessories.ISO9001: The design, manufacture, distribution, service and installation of research and development
and in-vitro diagnostic products.
Single
Bowling Green
KY
USA
ISO 9001:2008
The Design, Manufacture and Distribution of Lubrication Systems and Components.
MD and CMDCAS Scope: The design, maufacture and distribution of powered stimulators, biofeedback devices,electrodes,lead wires and othosis devices
for the Gastroenterology & Urology, Neurology and Physical Medicine areas.
Design, Manufacturing, Installation and Service of Water Purification System for Medical Applications.ISO 9001 Scope: Design, Contract Development,
Manufacturing, Installation and Service of Water Purification System for Industrial, Commercial and Pharmaceutical Applications.
The provision of quality inspection, sorting, containment, and rework services to commercial and automotive manufacturers and distributors.
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
COMPANY
Profile
Type
CITY
STATE
Country
Scheme
Bob Johnson Associates, Inc.
Single
Leominster
MA
USA
EN ISO 13485:2012
The Manufacture and Distribution of Permanent Magnet Components for the Medical Device Industry
Boekel Scientific
Single
Feasterville
PA
USA
EN ISO 13485:2012
ISO 13485 Scope: The Design, Manufacture and Distribution of Active Blood and Plasma Warming Devices.9K Scope: The Design, Manufacture and
Distribution of Life Science and General Laboratory Equipment Servicing the Medical, Pharmaceutical, Biotech and Life Science Markets.
Bon Secours Hospital
Single
Co. Galway
Ireland
EN ISO 13485:2012
The Provision of Disinfection and Sterilisation Services for Re-usable Invasive Medical Devices.
Bonding Source
Single
Nashua
NH
USA
ISO 9001:2008
Value Added Re-Seller of Epoxies and Related items for the Microelectronics and RF/Microwave Industries
Bovie Screen Process Printing Co., Inc.
Single
Bow
NH
USA
ISO 9001:2008
The Provision of Manufactured Printed Products such as Membrane Switches, Overlays, Decals, Labels and Direct Product Markings.
Boyd Technologies, Inc.
Single
South Lee
MA
USA
EN ISO 13485:2012
Boyle Transportation
Single
Billerica
MA
USA
ISO 9001:2008
Motor carrier transportation of shipments that require extensive safety and security
Brantner & Associates, Inc.
Primary
El Cajon
CA
USA
ISO 9001:2008
Design Engineering, Manufacturing, Quality Control and Testing for Harsh Environment, Underwater Connectors, Cable Assemblies and System Solutions.
Brantner & Associates, Inc.
Secondary
El Cajon
CA
USA
ISO 9001:2008
Design Engineering, Manufacturing, Quality Control and Testing for Harsh Environment, Underwater Connectors, Cable Assemblies and System Solutions.
Bristol Tape Corporation
Single
Fall River
MA
USA
ISO 9001:2008
Converter of pressure sensitive and non-sensitive films, foils and tapes
Brivant Limited
Single
Co. Galway
Ireland
ISO 13485/CMDCAS
Broadcast Microwave Services, Inc.
Single
Poway
CA
USA
ISO 9001:2008
Design and Manufacture of Microwave Communications Equipment for the Television Broadcast, Surveillance, Homeland Security and Law Enforcement
Industries.
Brooks Automation
Single
Fremont
CA
USA
ISO 9001:2008
Design, manufacture, installation, service and technical support of integrated automation solutions for the semiconductor, green and life sciences
industries.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Scope
MD Scope: The Manufacturing, Converting, Packaging, and Distribution of Advanced Flexible Roll-to-Roll Materials for the Medical Device Industry.ISO9K
Scope: The Manufacturing, Converting, Packaging, and Distribution of Advanced Flexible Roll-to-Roll Materials.
CMDCAS & MD Scope: The design, manufacture & distribution of interventional guide wires and components. The coating and packaging of sterile and
non-sterile interventional devices including catheters.
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
BWT Pharma & Biotech Ltd.
Single
Dublin
C & G Machine Tool Company, Inc.
Single
Granby
C.J. Electrical Contracting Inc.
Single
Calex Manufacturing Co., Inc.
COMPANY
Country
Scheme
Ireland
EN ISO 13485:2012
MA
USA
ISO 9001:2008
Medford
NY
USA
TL 9000 R5.0/5.0
Primary
Concord
CA
USA
ISO 9001:2008
The design, manufacture and sales of DC/DC, AC/DC Power Conversion Products, Instrumentation Products and LED Drivers
Caliper Life Sciences,
Secondary
Hopkinton
MA
USA
ISO 9001:2008
The Design, Manufacture, Sales and Support of Laboratory Automation Equipment and Services.
Caliper Life Sciences,
Primary
Hopkinton
MA
USA
ISO 9001:2008
The Design, Manufacture, Sales and Support of Laboratory Automation Equipment and Services.
Caliper Life Sciences, Inc.
Primary
Hopkinton
MA
USA
EN ISO 13485:2012
The Design, Manufacture and Distribution of In-Vitro Diagnostic Systems for evaluation of DNA fragments for diagnosis of disease, infection and
abnormalities.
Caliper Life Sciences, Inc.
Secondary
Hopkinton
MA
USA
EN ISO 13485:2012
The Design, Manufacture and Distribution of In-Vitro Diagnostic Systems for evaluation of DNA fragments for diagnosis of disease, infection and
abnormalities.
Cambridge International Systems, Inc.
Single
Arlington
VA
USA
ISO 9001:2008
Cambridge Isotope Laboratories, Inc.
Secondary
Andover
MA
USA
EN ISO 13485:2012
The Design and Development, Manufacture and Distribution of Neonatal Standard Reference Material for use in Screening, Diagnosis and Monitoring of
Metabolic Disorders including Phenylketonuria.
Cambridge Isotope Laboratories, Inc.
Primary
Tewksbury
MA
USA
EN ISO 13485:2012
The Design and Development, Manufacture and Distribution of Neonatal Standard Reference Material for use in Screening, Diagnosis and Monitoring of
Metabolic Disorders including Phenylketonuria.
Canadian Standards Association
Single
Mississauga
Canada
ISO 14001:2004
Standards development and related services
Canadian Standards Association
Single
Mississauga
Canada
CSA-Z1000:2006
Standards development and related services
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
STATE
ON
Scope
MD scope: The Design, Manufacture, Installation, Commissioning and Servicing of Water Purification Systems for Use in Haemo Dialysis Treatment.9k
scope: The Design, Manufacture, Installation, Commissioning and Servicing of Water Purification Systems.
The manufacturing and sale of machined components and fabricated assemblies for commercial and defense related customers
TL9000-V Scope: A Full Service Provider of Engineering, Furnishing and Installation for the Telecommunications Industry Specializing in Power AC/DCand
Network Systems for the following Service Categories: 7.1.1 Installation and 7.2.1.1 Fix Network Engineering.ISO9K Scope: A Full Service Provider of
Engineering, Furnishing and Installation for the Telecommunications Industry Specializing in Power AC/DC and Network Systems.
Design and Provisioning of National Security and Defense Services.
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
Scope
Candelis, Inc.
Single
Newport Beach
CA
USA
ISO 13485/CMDCAS
The design, manufacture and distribution of Picture Archiving and Communications Systems (PACS), Radiology Information Systems (RIS), RT, Radiology
and Mammography Viewers.
Cannon Fabrication Company
Single
Milroy
IN
USA
ISO 9001:2008
Caragh Precision
Single
Galway
Ireland
EN ISO 13485:2012
Cardinal Manufacturing Company
Single
Louisville
USA
ISO 9001:2008
The Manufacture of Roll Formed Shaped Products from Customer Specifications.
Cardio3 BioSciences SA/NV
Single
Mont-Saint-Guibert
Belgium
ISO 13485:2003
The design and development, manufacture and distribution of sterile cardiovascular catheters
Cardiox Corporation
Single
Columbus
OH
USA
EN ISO 13485:2012
Carlsbad International Export Inc.
Single
Carlsbad
CA
USA
ISO 13485:2003
Manufacture and distribution of consumable medical accessories for ventilation products.
Carolina Laser Cutting Inc.
Single
Greensboro
NC
USA
ISO 9001:2008
The provision of high precision CO2 laser cutting and sheet metal fabrication services.
Caspers Distribution Company
Single
Tampa
FL
USA
ISO 14001:2004
Distribution of restaurant food and supplies
CASWELL, INC.
Single
New Taipei City
Taiwan
TL 9000 R5.0/5.0
ISO 9001 Scope:Design and Sales of Server, Network Related Server, and M/B & NIC.TL 9000-H Scope:Design and Sales of Server, Network Related
Server, and M/B & NIC for the Product Category: 8.2.3-High Complexity Electronic Assemblies.
Cervical Check
Single
Co Limerick
Ireland
ISO 9001:2008
Charles Industries, Ltd.
Primary
Rolling Meadows
IL
USA
TL 9000 R5.0/5.0
The design, manufacture and sale of telecommunications, CATV and marine and industrial products.TL9000-H for the following hardware product
category: 3.1.2.1 Enclosures.
Charles Industries, Ltd.
Secondary
Canton
MO
USA
TL 9000 R5.0/5.0
The design, manufacture and sale of telecommunications, CATV and marine and industrial products.TL9000-H for the following hardware product
category: 3.1.2.1 Enclosures.
COMPANY
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
KY
The manufacture of sound deadening products, die cut parts and assemblies.
MD Scope: The manufacture of precision machined components and products for medical devices including passivation, cleaning and cleanroom
manufacturing.ISO9K Scope: The manufacture of precision machined components.
The design, manufacture and distribution of active diagnostic medical devices that utilize detection of indicator dyes to evaluate circulatory and metabolic
abnormalities.
The management of the National Cervical Screening Programme
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
Charles Industries, Ltd.
Secondary
Casey
IL
USA
TL 9000 R5.0/5.0
The design, manufacture and sale of telecommunications, CATV and marine and industrial products.TL9000-H for the following hardware product
category: 3.1.2.1 Enclosures.
Charles Industries, Ltd.
Secondary
Marshall
IL
USA
TL 9000 R5.0/5.0
The design, manufacture and sale of telecommunications, CATV and marine and industrial products.TL9000-H for the following hardware product
category: 3.1.2.1 Enclosures.
Charles Industries, Ltd.
Secondary
Rantoul
IL
USA
TL 9000 R5.0/5.0
The design, manufacture and sale of telecommunications, CATV and marine and industrial products.TL9000-H for the following hardware product
category: 3.1.2.1 Enclosures.
Charng Huah Electronic Co., Ltd.
Single
Taoyuan Hsien
Taiwan, R.O.C.
TL 9000 R5.0/5.0
ISO9K Scope: Surface Mount Technology (SMT), Insertion, Assembly of Printed Circuit Board and Finished Products.TL 9000-H Scope: Surface Mount
Technology (SMT), Insertion, Assembly of Printed Circuit Board and Finished Products, Product Category: 8.2.4-Very High Complexity Subassemblies Direct Suppliers.
Charter Medical Ltd
Single
Winston Salem
NC
USA
ISO 13485/CMDCAS
The design, manufacture and distribution of Medical Devices used in collection, storage and processing of blood and blood components to include tubing,
connectors, syringes, mesh filters and bags.The manufacture and distribution of foam, felt and knit components for medical applications.The design,
manufacture and distribution of disposable bio-containers.
CHD Bioscience, Inc.
Primary
Fort Collins
CO
USA
EN ISO 13485:2012
The design and development of chemical solutions for the disinfection and sterilization of reusable medical devices
CHD Bioscience, Inc.
Secondary
Fort Collins
CO
USA
EN ISO 13485:2012
The design and development of chemical solutions for the disinfection and sterilization of reusable medical devices
Chromatics, Inc.
Single
Bethel
CT
USA
ISO 9001:2008
The Design and Manufacture of Fluoropolymer Color Concentrates and Compounds.
Circuit Technology, Inc
Single
Merrimack
NH
USA
ISO 9001:2008
Sales and Production of Electronic Assemblies
City of Austin
Secondary
Austin
TX
USA
ISO 9001:2008
Distribution, Transmission, and Substation Services; Project Management; Complex Metering
City of Austin
Secondary
Austin
TX
USA
ISO 9001:2008
Distribution, Network and Illumination Services: Project Management; HVAC
City of Austin, Austin Energy
Secondary
Austin
TX
USA
ISO 9001:2008
System Maintenence & Restoration
City of Austin, Austin Energy
Secondary
Austin
TX
USA
ISO 9001:2008
Calibration; Transformer Sets
COMPANY
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Scope
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
Primary
Austin
TX
USA
ISO 9001:2008
Single
Anaheim
CA
USA
ISO 13485/CMDCAS
The design, manufacture and distribution of sterile, disposable chest drainage catheters and systems.
Cliniqa Corporation
Secondary
San Marcos
CA
USA
ISO 13485/CMDCAS
The design, development and manufacture of in-vitro diagnostic controls, calibrators, raw materials, reagents and kits for the diagnosis, management,
detection of blood analytes, blood components, cardiac markers, cancer, therapeutic drug monitoring,and drugs of abuse.
Cliniqa Corporation
Primary
San Marcos
CA
USA
ISO 13485/CMDCAS
The design, development and manufacture of in-vitro diagnostic controls, calibrators, raw materials, reagents and kits for the diagnosis, management,
detection of blood analytes, blood components, cardiac markers, cancer, therapeutic drug monitoring,and drugs of abuse.
Clover Environmental Solutions
Single
Oglesby
IL
USA
ISO 9001:2008
Collection, Sorting and Distribution of Toner and Ink Printer Cartridges, Printers and Other Small Electronic Devices
Clover Environmental Solutions
Single
Mexicali B.C.
México
ISO 14001:2004
Receiving, processing, warehousing and distribution of recycled printer cartridges, cell phones and other small electronic devices.
Clover Environmental Solutions
Single
Oglesby
USA
ISO 14001:2004
Collection, Sorting and Distribution of Toner and Ink Printer Cartridges, Printers and Other Small Electronic Devices
Clover Technologies Canada, ULC
Single
Ontario
Canada
ISO 9001:2008
Collection of recycled cartridges and warehousing and distribution of laser, inkjet, impact printer cartridges and other printing related consumables.
Clover Technologies Group
Secondary
Ithaca
MI
USA
ISO 9001:2008
Design, Manufacturing, Remanufacturing and Distribution of Inkjet Cartridges and Other Printing Related Consumables
Clover Technologies Group
Primary
Calexico
CA
USA
ISO 9001:2008
Warehousing and distribution of laser, inkjet, impact printer cartridges, wireless devices and other printing related consumables.
Clover Technologies Group
Secondary
Calexico
CA
USA
ISO 9001:2008
Warehousing and distribution of laser, inkjet, impact printer cartridges, wireless devices and other printing related consumables.
Clover Technologies Group
Primary
Ottawa
IL
USA
ISO 9001:2008
Design, manufacturing, and/or distribution of laser, inkjet, impact printer cartridges and other printing related consumables.
Clover Technologies Group
Primary
Ithaca
MI
USA
ISO 9001:2008
Design, Manufacturing, Remanufacturing and Distribution of Inkjet Cartridges and Other Printing Related Consumables.
COMPANY
City of Austin, Austin Energy
ClearFlow, Inc.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
IL
Scope
Delivering electric power to Austin Energy's customers by planning, designing, constructing, operating, and maintaining its electric service delivery
infrastructure, operating systems, and equipment.
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
Clover Technologies Group
Single
Plano
TX
USA
ISO 9001:2008
Warehousing and distribution of laser, inkjet, impact printer cartridges and other printing related consumables and parts.
Clover Technologies Group
Secondary
Oglesby
IL
USA
ISO 14001:2004
Collection, Sorting and Distribution of Toner and Ink Printer Cartridges, Printers and Other Small Electronic Devices
Clover Technologies Group
Secondary
Oglesby
IL
USA
ISO 9001:2008
Collection, Sorting and Distribution of Toner and Ink Printer Cartridges, Printers and Other Small Electronic Devices
Clover Technologies Group
Secondary
Ottawa
IL
USA
ISO 9001:2008
Design, manufacturing, and/or distribution of laser, inkjet, impact printer cartridges and other printing related consumables.
Single
Farmingdale
NJ
USA
ISO 9001:2008
Collection, Design, Repair, Re-manufacturing and Distribution of printer parts.
Clover Telecom Asset Management, LLC.
Secondary
Irving
TX
USA
ISO 14001:2004
Repair and Return of Telecommunications Products.
Clover Telecom Asset Management, LLC.
Primary
Irving
TX
USA
ISO 14001:2004
Repair and Return of Telecommunications Products.
Coatings 2 Go, LLC
Single
Carlisle
MA
USA
EN ISO 13485:2012
CohuHD Costar, LLC.
Single
Poway
CA
USA
ISO 9001:2008
Combe Laboratories Inc.
Single
Rantoul
IL
USA
EN ISO 13485:2012
English Scope: Manufacturing of denture adhesive seals, feminine wipes, powder and liquid feminine douches, and vaginal infection screening
kits.Spanish Translated Scope: Fabricante de almohadillas adhesivas para dentadura postiza, toallas femeninas, polvos y líquidos para duchas femeninas
y kits de prueba para infecciones vaginales.
Combe Products, Inc
Single
Naguabo
Puerto Rico
EN ISO 13485:2003
The manufacture and distribution of non-biological gels for vaginal use.
Compal Networking (Kunshan) Co., Ltd
Single
Kunshan
China
TL 9000 R5.0/5.0
Componentes Intel de Costa Rica S. A.
Secondary
Heredia
Costa Rica
ISO 9001:2008
COMPANY
Clover Technologies Group, LLC
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Scope
The Manufacture and Distribution of Coatings for use in the Medical Device Industry.
The Research, Design, Manufacture, Distribution, and Servicing of Cameras, Advanced Video Products and Systems.
ISO 9000 Scope: Production of Broadband Networking Equipment (Wireless Card, Gateway, Access Point and High End Router).TL Scope-H: Production
of Broadband Networking Equipment (Wireless Card, Gateway, Access Point and High End Router for the Product Category: 7.7.4 Electromechanical
Assembly.
Assemble and Test Semiconductor Components, Associated Equipment and Processes.
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
Componentes Intel de Costa Rica S. A.
Secondary
Componentes Intel de Costa Rica S.A.
COMPANY
Country
Scheme
Heredia
Costa Rica
ISO 14001:2004
The manufacturing of semiconductors.
Secondary
Heredia
Costa Rica
OHSAS 18001:2007
The manufacturing of semiconductors.
Computer Cite (CCITE)
Single
San Ramon
CA
USA
ISO 9001:2008
Provision of contract staffing services and special project services.
Computer Services Dept. of the CSIU
Single
Milton
PA
USA
ISO 9001:2008
Development, Sales, Training, and Support of Financial, Student and Tax Software for Schools.
Comstock Industries
Single
Meredith
NH
USA
ISO 9001:2008
Manufacture of Ferrous and Non-Ferrous, Plastic and Polyurethane Products.
Comtran Cable, LLC
Single
South Attleboro
MA
USA
ISO 9001:2008
Design and Manufacture of Wire and Cable for Electrical, and Voice and Data Communications Applications.
Contech Medical, Inc.
Single
Providence
RI
USA
I.S.EN ISO13485:2012
Controls for Automation
Primary
Taunton
MA
USA
EN ISO 13485:2012
MD Scope: The manufacture and distribution of components and assemblies for the medical device industry.ISO9K Scope: The manufacture and
distribution of components, manufactured products and assemblies for various industries that include medical.
Controls for Automation
Secondary
Gilford
NH
USA
EN ISO 13485:2012
MD Scope: The manufacture and distribution of components and assemblies for the medical device industry.ISO9K Scope: The manufacture and
distribution of components, manufactured products and assemblies for various industries that include medical.
Conventus Orthopaedics, Inc
Single
Maple Grove
MN
USA
ISO 13485/CMDCAS
The Design, Manufacture and Distribution of Non-Active Orthopaedic Implants and Associated Accessories.
Core Sound Imaging, Inc.
Single
Raleigh
NC
USA
EN ISO 13485:2012
The Design, Development and Distribution of Web-Based Picture Archival and Communications Systems (PACS), Including Software.
Core Technology Molding Corp
Single
Greensboro
NC
USA
ISO 9001:2008
Corfin Industries LLC
Single
Salem
NH
USA
AS 9100 - C
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
STATE
Scope
Contract Assembly and Packaging of OEM Medical Device Components and Assemblies.
The inspection, rework, assembly of secondary plastics and molding processes
Trim, Form, BGA reballing, J-lead Attach, and Robotic Hot Solder Dip of Electronic Devices, Including Component Preparation and Termination Finish
Conversion for RoHS Compliance, and the Elimination of Tin Whisker and Gold Embrittlement Risks.
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
Corning Incorporated
Primary
Durham
NC
USA
EN ISO 13485:2012
The Design, Manufacture and Distribution of Sterile Fluid Handling and Tissue Culture Products.
Corning Incorporated
Secondary
Tewksbury
MA
USA
EN ISO 13485:2012
The Design, Manufacture and Distribution of Sterile Fluid Handling and Tissue Culture Products.
Corning Life Sciences
Single
Durham
NC
USA
ISO 14001:2004
Manufacture and Distribution of Sterile Fluid Handling and Tissue Culture Products.
Corning, Inc.
Single
Woburn
MA
USA
ISO 9001:2008
The Design and Manufacture of Products for Research Use Only in Life Sciences Research
Corning, Inc.
Single
Bedford
MA
USA
ISO 9001:2008
The Design and Manufacture of Products for Research use only in Life Sciences Research.
Cosman Medical, Inc.
Single
Burlington
MA
USA
ISO 13485/CMDCAS
Craftech Industries, Inc.
Single
Hudson
NY
USA
ISO 9001:2008
Creation Technologies
Secondary
Santa Clara
CA
USA
EN ISO 13485:2012
Creation Technologies
Primary
Santa Clara
CA
USA
ISO 9001:2008
The provision of electronic manufacturing and sustaining services.
Creation Technologies
Secondary
Milpitas
CA
USA
ISO 9001:2008
The provider of electronic manufacturing services and sustaining services.
Creation Technologies
Primary
Santa Clara
CA
USA
EN ISO 13485:2012
Electronic manufacturing service provider, specializing in PCBA Assembly and System Integration for Medical Devices.
Creation Technologies
Secondary
Milpitas
CA
USA
EN ISO 13485:2012
Manufacturing of electronic printed circuit board assemblies and system integration of printed circuit board assemblies into finished electronic equipment.
Single
Biddeford
ME
USA
ISO 9001:2008
COMPANY
CRI-SIL Silicone Technologies, LLC
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Scope
The design and development, manufacture, servicing and distribution of RF Lesion generators and associated sterile and non-sterile RF electrodes and
injection needles for surgical use.
Fabrication of high performance fasteners and components.
Electronic manufacturing service provider, specializing in PCBA Assembly and system Integration for Medical Devices.
Manufacturer and Delivery of Performance Elastomer Products and Services
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
Critical Care Diagnostics Inc.
Secondary
San Diego
CA
USA
ISO 13485/CMDCAS
The Design, Manufacture and Distribution of ST2 In-Vitro Diagnostic Assay and Related Controls for Professional Use.
Critical Care Diagnostics, Inc.
Primary
San Diego
CA
USA
ISO 13485/CMDCAS
The Design, Manufacture and Distribution of ST2 In-Vitro Diagnostic Assay and Related Controls for Professional Use.
Secondary
Dublin 4
Ireland
EN ISO 13485:2012
The Design, Manufacture and Distribution of ST2 In-Vitro Diagnostic Assay and Related Controls for Professional Use.
Critical Process Filtration, Inc.
Single
Nashua
USA
ISO 9001:2008
Croom Precision Medical Ltd
Single
Co. Limerick
Ireland
EN ISO 13485:2012
The manufacture of precision medical device components.
CROSSTEX International, Inc.
Secondary
Hauppauge
NY
USA
ISO 13485/CMDCAS
The Design and Manufacture of Surgical Face Masks, Examiniation Gloves, Disposable Prophy Angles, Saliva Ejectors, Evacuator tips and Non-Sterile
Single-Use Barrier Products for the Healthcare Industry
CROSSTEX International, Inc.
Primary
Hauppauge
NY
USA
ISO 13485/CMDCAS
The Design and Manufacture of Surgical Face Masks, Examiniation Gloves, Disposable Prophy Angles, Saliva Ejectors, Evacuator tips and Non-Sterile
Single-Use Barrier Products for the Healthcare Industry
CROSSTEX International, Inc.
Secondary
Sharon
PA
USA
ISO 13485/CMDCAS
The Design and Manufacture of Surgical Face Masks, Examiniation Gloves, Disposable Prophy Angles, Saliva Ejectors, Evacuator tips and Non-Sterile
Single-Use Barrier Products for the Healthcare Industry
CSA Group
Single
Cleveland
OH
USA
CSA-Z1000:2006
Testing and Certification of Products/ Standards
CSA Group
Single
Richmond, British
Columbia
Canada
CSA-Z1000:2006
Product Testing and Product Certification
CSA Group
Single
Toronto
ON
Canada
CSA-Z1000:2006
Product Testing and Certification
CSA Group
Primary
Rexdale
ON
Canada
ISO 9001:2008
The provision of financial management and operational management support services for CSA Group.
CSA Group
Secondary
Cleveland
OH
USA
ISO 9001:2008
The provision of financial management and operational management support services for CSA Group.
COMPANY
Critical Diagnostics Limited
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
NH
Scope
Manufacture and Distribution of Filter Systems for diverse industries including Medical Devices.
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
CSA Group
Single
Irvine
CA
USA
ISO 14001:2004
Product Testing and Product Certification
CSA Group
Single
Irvine
CA
USA
CSA-Z1000:2006
Product testing and product certification.
CSA Group
Single
Richmond, British
Columbia
Canada
ISO 14001:2004
Product Testing and Product Certification
CSA Group
Single
Toronto
ON
Canada
ISO 14001:2004
Product Testing and Certification
CSA Group
Single
Cleveland
OH
USA
ISO 14001:2004
Testing and Certification of Products/ Standards
CSA International
Single
Alberta
Canada
CSA-Z1000:2006
Product testing and product certification.
CSA International
Single
Alberta
Canada
ISO 14001:2004
Product testing and product certification.
CTT, Inc.
Single
Sunnyvale
CA
USA
AS 9100 - C
Cubbison Company
Single
Youngstown
OH
USA
ISO 9001:2008
Design and manufacture of custom product identification solutions (e.g. Cut Film Graphics, Domed Labels, Overlays, Label Kits, Industrial Labels and
Metal Nameplates).
Cugreen Metal Tech. Co., Ltd.
Single
Taoyuan County
Taiwan, R.O.C.
ISO 9001:2008
ISO9K: Design and development, manufacturing and sales for copper oxide and copper carbonate, materials for copper plating process of PCB and semiconductor industries.
Cugreen Metal Tech. Co., Ltd.
Single
Taoyuan County
Taiwan, R.O.C.
QC 080000
IECQ: Design and development, manufacturing and sales for copper oxide and copper carbonate, materials for copper plating process of PCB and semiconductor industries, applicable to European Directive 2011/65/EU and customer specified requirements.
Cuprime Material Co. Ltd
Single
Taoyuan County
Taiwan, R.O.C.
ECCB HSPM
COMPANY
CVRx, Inc.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single
Minneapolis
MN
USA
ISO 13485/CMDCAS
Scope
Design and manufacture of Microwave Power Amplifiers, Frequency Converters, Frequency Multipliers, Transmitters, Transceivers and Subsystems within
the Frequency Range of 300MHz to 110GHz using MIC Hybrid Technology.
Manufacture and sales of high purity bare copper bar and wire for cords and cables, including 8.0 mm and 2.6 mm sizes.
CMDCAS Scope: The design, manufacture and distribution of implantable and external pulse generators, programmer / external systems, implantable and
temporary electrode / leads, surgical tool kits, and accessory kits.MD Scope: The design, manufacture and distribution of implantable and external pulse
generators, programmer / external systems, implantable and temporary electrode / leads, surgical tool kits, and accessory kits for the treatment of
cardiovasculardisease
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
CWS-boco
Single
Dublin 22
Cytonome/ST, LLC
Single
Boston
DALTON MANUFACTURING COMPANY INC
Single
Data Exchange Corp
Data Exchange Europe Ltd
COMPANY
STATE
Country
Scheme
Scope
Ireland
I.S.EN ISO13485:2012
MA
USA
ISO 9001:2008
Design, Manufacture, Sales, and Service of Cell Purification Systems and Technologies for BioMedicine, BioIndustry and BioScience.
AMESBURY
MA
USA
ISO 9001:2008
The machining of customer designed parts and assemblies including medical.
Single
Camarillo
CA
USA
EN ISO 13485:2012
MD Scope: The repair, exchange, sale, end of life support, and logistics services for electronic, computer, communications, medical equipment and
components.ISO9K Scope: The repair, exchange, sale, end of life support, and logistics services for electronic, computer, and communication equipment
and components.
Single
Dublin 17
Ireland
EN ISO 13485:2012
MD Scope: The service & repair of active medical imaging equipment.ISO9K Scope: The repair, exchange, sale and support of equipment as well as
logistic services for the electronic, communication, medical and renewable energy industries.
Dataproducts Imaging Solutions SA de CV
Secondary
Mexicali B.C.
Mexico
ISO 9001:2008
The Collection, Processing, Warehousing, Manufacturing, Re-manufacturing and Distribution of laser recycled printer cartridges and related consumables;
processing, warehousing and distribution of cell phones and other small electronic devices.
Dataproducts Imaging Solutions SA de CV
Secondary
Mexicali B.C.
Mexico
ISO 9001:2008
The Collection, Processing, Warehousing, Manufacturing, Re-manufacturing and Distribution of laser recycled printer cartridges and related consumables;
processing, warehousing and distribution of cell phones and other small electronic devices.
Dataproducts Imaging Solutions SA de CV
Primary
Mexicali B.C.
Mexico
ISO 9001:2008
The Collection, Processing, Warehousing, Manufacturing, Re-manufacturing and Distribution of laser recycled printer cartridges and related consumables;
processing, warehousing and distribution of cell phones and other small electronic devices.
Dayton Forging and Heat Treating
Single
Dayton
OH
USA
ISO 9001:2008
Forging, heat treating and machining of steel and alloys.
Deco-Chem Inc
Single
Mishawaka
IN
USA
ISO 9001:2008
Manufacture of Ink
Delfi Medical Innovations Inc.
Single
Canada
ISO 13485/CMDCAS
The manufacture, packaging and distribution of sterile and non-sterile surgical supplies, gowns, wound dressings, drapes, including sterile procedure
packs
The Design and Development, Manufacture and Service of Tourniquet Systems, Sterile and Non-Sterile Tourniquet Cuffs.
Dell (Chengdu) Company Limited
Secondary
Chengdu, Sichuan
China
ISO 9001:2008
Manufacture and Supply of Computers, and Associated Hardware and Software and Related Management Activities.
Dell (Chengdu) Company Limited
Secondary
Chengdu, Sichuan
China
ISO 14001:2004
Manufacture and Supply of Computers and Technology Products.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
Dell (Chengdu) Company Limited
Secondary
Dell (China) Co. Ltd (CCC5)
COMPANY
Country
Scheme
Chengdu, Sichuan
China
OHSAS 18001:2007
Secondary
Xiamen
China
ISO 9001:2008
Manufacture, Sales, Sales Operations, Customer Service & Support and Supply of Computers, and Associated Hardware and Software Related Activities
Dell (China) Co. Ltd.
Secondary
Fujian
China
ISO 9001:2008
Manufacture and Supply of Computers, Server, Storage, Associated Hardware, Software, Related Activities and All Provisions of Sales, Sales Operations,
Customer Service, Support, and Customer Care for Computers, Server, Storage, Technology Productsand Solutions.
Dell (China) Co. Ltd. (CCC2)
Secondary
Fujian
China
ISO 14001:2004
The manufacture and supply of computers, servers, storage and associated hardware and software.
Dell (China) Co., Ltd.
Secondary
Dalian
China
ISO 9001:2008
All Provisions of Customer Service, Support, Sales, Sales Operations and Customer Care for Computers, Technology Products and Solutions
Dell (China) Co., Ltd.
Secondary
Fujian
China
OHSAS 18001:2007
Dell (China) Co., Ltd.
Secondary
Beijing
China
ISO 9001:2008
All Provisions of Customer Service, Support and Sales Operations for Computers, Technology Products and Solutions
Dell (Taiwan) B.V., Taiwan Branch
Secondary
Taipei
Taiwan
ISO 9001:2008
The Design, Development, Customer Services and Supporting Functions of Computers and Technology Products and Services
Dell (Xiamen) Co. Ltd.
Secondary
Fujian
China
ISO 9001:2008
Manufacture and Supply of Computers, Server, Storage, Associated Hardware, Software, Related Activities and All Provisions of Sales, Sales Operations,
Customer Service, Support, and Customer Care for Computers, Server, Storage, Technology Productsand Solutions.
Dell (Xiamen) Co. Ltd. (CCC4)
Secondary
Fujian
China
OHSAS 18001:2007
The manufacture and supply of computers, servers, storage and associated hardware and software.
Dell (Xiamen) Co. Ltd. (CCC4)
Secondary
Fujian
China
ISO 14001:2004
The manufacture and supply of computers, servers, storage and associated hardware and software.
Dell A/S
Secondary
Copenhagen
Denmark
ISO 9001:2008
All Provisions of Customer Service and Support, Sales Operations and Customer Care for Computers, Technology Products and Solutions
Dell AB
Secondary
Solna
Sweden
ISO 9001:2008
All Provisions of Customer Service, Support, Sales Operations and Customer Care for Computers, Technology Products and Solutions
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
STATE
Scope
Manufacture and Supply of Computers and Technology Products.
The manufacture and supply of computers, servers, storage and associated hardware and software.
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
Dell AS
Secondary
Dell Asia Pacific Sdn. Bhd.
COMPANY
Country
Scheme
Oslo
Norway
ISO 9001:2008
All Provisions of Customer Service, Support, Sales Operations and Customer Care for Computers, Technology Products and Solutions
Secondary
Penang
Malaysia
ISO 9001:2008
Regional Procuement and Information Technology Services, Regional Centre for Engineering, Manufacturing, Fulfilment & Delivery, Logistics and Quality
Management. Global Manufacturing for Computers, Technology Products and Services.
Dell Asia Pacific Sdn. Bhd. (APCC2)
Secondary
Penang
Malaysia
OHSAS 18001:2007
Dell Asia Pacific Sdn. Bhd. (APCC2)
Secondary
Penang
Malaysia
ISO 14001:2004
The manufacture and supply of computers and technology products.
Dell Australia Pty Limited
Secondary
Sydney, New South
Wales
Australia
ISO 9001:2008
Sales, Sales Operations, Customer Service and Support for a range of desktop, server and notebook computers and associated peripherals.
Dell B.V.
Secondary
AK Amsterdam
Netherlands
ISO 9001:2008
All Provisions of Customer Service, Support, Sales Operations and Customer Care for Computers, Technology Products and Solutions
Dell Canada
Secondary
North York, Ontario
Canada
ISO 9001:2008
All Provisions of Customer Service, Support, Sales Operations and Customer Care for Computers, Technology Products and Solutions
Dell Cloud Clinical Archive (DCCA)
Single
Wallingford
USA
EN ISO 13485:2012
Dell Computadores do Brazil Ltda
Secondary
Hortolândia, SP 13.184654
Brazil
ISO 14001:2004
The manufacture and supply of computers and technology products.
Dell Computadores do Brazil Ltda.
Secondary
Hortolândia, SP 13.184654
Brazil
ISO 9001:2008
Manufacture, Fulfillment & Delivery, Re-Furbishment and All Provisions of Customer Service, Support and Customer Care for Computers, Technology
Products and Solutions
Dell Computadores do Brazil Ltda.
Secondary Eldorado do Sul - CEP
Brazil
ISO 9001:2008
All Provisions of Customer Service, Support, Sales Operations and Customer Care for Computers, Technology Products and Solutions
Dell Computer S.A. (Spain)
Secondary
Madrid
Spain
ISO 9001:2008
All Provisions of Customer Service, Support, Sales Operations and Customer Care for Computers, Technology Products and Solutions
Dell Computer Services de Mexico,
Secondary
Jalisco
Mexico
ISO 9001:2008
The provision of infrastructure ITO services at the Guadalajara Service Center
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
STATE
CT
Scope
Manufacture and supply of computers and technology products.
Design and Development, Manufacture, Test, Service and Distribution of Software for Secure Storage and Retrieval of Medical Patient Data and Image
Files
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
Dell Computer spol. s.r.o.
Secondary
Dell Computers S.A. (South Africa)
COMPANY
Country
Scheme
Prague
Czech Republic
ISO 9001:2008
All Provisions of Customer Service and Support, Sales Operations and Customer Care for Computers, Technology Products and Solutions
Secondary
Johannesburg
South Africa
ISO 9001:2008
All Provisions of Customer Service, Support, Sales Operations and Customer Care for Computers, Technology Products and Solutions
Dell Corporation (Thailand) Co., Ltd.
Secondary
Bangkok
Thailand
ISO 9001:2008
All Provisions of Customer Service and Support for Computers, Technology Products and Solutions
Dell Corporation Ltd
Secondary
Nottingham
United Kingdom
ISO 9001:2008
The provision of infrastructure ITO services in the United Kingdom
Dell Corporation Ltd
Secondary
Bracknell, Berkshire
United Kingdom
ISO 9001:2008
All Provisions of Customer Service, Support, Sales Operations and Customer Care for Computers, Technology Products and Solutions
Dell Corporation Ltd
Secondary
London
United Kingdom
ISO 9001:2008
The Provision of Project Management, IT Consultancy, Systems Integration, Software Deployment and Support by the Healthcare Group of Dell Services,
Europe.
Dell Corporation Ltd.
Secondary
Glasgow
United Kingdom
ISO 9001:2008
All Provisions of Customer Service, Support, Sales Operations and Customer Care for Computers, Technology Products and Solutions
Dell Force 10
Secondary
San Jose
CA
USA
ISO 9001:2008
The design, development and supporting functions for networking products and services.
Dell Force 10
Secondary
Petaluma
CA
USA
ISO 9001:2008
The design, development and supporting functions for networking products and services.
Dell Global B.V. (Singapore Branch)
Secondary
Singapore
Singapore
ISO 9001:2008
The Design, Development, Product Line Marketing, provision of Customer Service, Support and Sales Operations for Computers, Technology Products
and Solutions.
Dell GmbH
Secondary
60549 Frankfurt am
Main
Germany
ISO 9001:2008
All Provisions of Customer Service, Support, Sales Operations and Customer Care for Computers, Technology Products and Solutions
Dell Halle GmbH
Secondary
Halle (Saale)
Germany
ISO 9001:2008
All Provisions of Customer Service, Support, Sales Operations and Customer Care for Computers, Technology Products and Solutions
DELL III- Comércio de Computadores,
Secondary
2740-298 Porto Salvo
Portugal
ISO 9001:2008
All Provisions of Customer Service, Support, Sales Operations and Customer Care for Computers, Technology Products and Solutions
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
STATE
Scope
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
Dell Inc.
Secondary
Dell Inc.
COMPANY
Country
Scheme
Tokyo
Japan
ISO 9001:2008
All Provisions of Customer Service, Support, Sales, Sales Operations and Customer Care for Computers, Technology Products and Solutions.
Secondary
Selangor Darul Ehsan
Malaysia
ISO 9001:2008
All Provisions of Customer Service, Support, Sales, Sales Operations and Customer Care for Computers, Technology Products and Solutions
Dell Inc.
Secondary
Bagumbayan, Quezon
City
Philippines
ISO 9001:2008
All Provisions of Customer Service, Support, Sales Operations and Customer Care for Computers, Technology Products and Solutions
Dell Inc.
Secondary
Penang
Malaysia
ISO 9001:2008
Regional call centre for sales operations and maintain sales, customer service and technical support. Regional administrative centre for marketing,
finance and information technology services. Global IT supports and global procurement.
Dell Inc.
Secondary
Round Rock
TX
USA
ISO 14001:2004
Global product development
Dell Inc.
Secondary
Round Rock
TX
USA
ISO 14001:2004
Global Takeback (Asset Resale and Recycling Services & Producer Responsibility).
Dell Inc.
Primary
Round Rock
TX
USA
ISO 9001:2008
The Design, Development, Manufacture, Procurement, Fulfillment, Delivery, Sales Operations, Customer Service, Take-Back & Recycling, Refurbishment
and Supporting Functions of Computers, Technology Products, Services and Solutions
Dell Inc.
Secondary
Nashville
TN
USA
ISO 9001:2008
The Fulfillment & Delivery, Sales Operations, Customer Service, and Supporting Functions of Computers and Technology Products and Services
Dell Inc.
Secondary
Dublin
Ireland
ISO 9001:2008
The Design, Development and Services and Solutions and Provisions of Customer Service, Support, Sales Operations and Customer Care for Computers,
Technology Products and Solutions
Dell Inc.
Secondary
Kanagawa
Japan
ISO 9001:2008
All Provisions of Customer Service, Support, Sales, Sales Operations and Customer Care for Computers, Technology Products and Solutions
Dell Inc.
Secondary
Miyazaki
Japan
ISO 9001:2008
All Provisions of Customer Service, Support, Sales, Sales Operations and Customer Care for Computers, Technology Products and Solutions
Dell Inc.
Secondary
Shanghai
China
ISO 9001:2008
Sales, Sales Operations, Customer Service and Supporting Functions of Computers and Technology Products and Services.
Dell Inc.
Secondary
Saint Denis (Paris)
France
ISO 9001:2008
All Provisions of Customer Service, Support, Sales Operations and Customer Care for Computers, Technology Products and Solutions
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
STATE
Scope
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
Dell Inc.
Secondary
Dell Inc.
COMPANY
Country
Scheme
Mexico City
Mexico
ISO 9001:2008
All Provisions of Customer Service, Support, Sales Operations and Customer Care for Computers, Technology Products and Solutions
Secondary
Panama City
Panama
ISO 9001:2008
All Provisions of Customer Service, Support, Sales Operations and Customer Care for Computers, Technology Products and Solutions
Dell Inc.
Secondary
Round Rock
TX
USA
ISO 9001:2008
The Design, Development, Manufacture, Delivery, Sales Operations, Fulfillment, Customer Service, and Supporting Functions of Computers and
Technology Products, Services and Solutions
Dell Inc.
Secondary
Round Rock
TX
USA
ISO 9001:2008
All Provisions of Sales Operations and Customer Care for Computers, Technology Products and Solutions for Federal Systems.
Dell Inc. (Compellent)
Secondary
Eden Prairie
MN
USA
ISO 9001:2008
The Design, Development, Sales Operations, Support, Services and Customer Care for Computers, Technology Products and Solutions.
Dell Inc. (Compellent)
Secondary
Eden Prairie
MN
USA
ISO 9001:2008
The Design, Development, Sales Operations, Support, Services and Customer Care for Computers, Technology Products and Solutions.
Dell Inc. (Copilot)
Secondary
Edina
MN
USA
ISO 9001:2008
The Design, Development, Sales Operations, Support, Services and Customer Care for Computers, Technology Products and Solutions.
Dell Inc. (KACE)
Secondary
Mountain View
CA
USA
ISO 9001:2008
The Design, Development and Supporting Functions for Deployment and Systems Management Appliances
Dell International Inc. (Korea)
Secondary
Seoul
Korea
ISO 9001:2008
All Provisions of Customer Service, Support, Sales Operations and Customer Care for Computers, Technology Products and Solutions
Dell International Services India
Secondary
Tamilnadu
India
ISO 9001:2008
Manufacture, Fulfilment & Delivery of Computers and Technology products requested by Dell sales centres for shipping to customers
Dell International Services India
Secondary
Kancheepuram,
Tamilnadu
India
ISO 14001:2004
Manufacture of Computers and Technology Products
Dell International Services India Pvt.
Secondary
Bangalore
India
ISO 9001:2008
All Provisions of Customer Service, Support, Sales Operations and Customer Care for Computers, Technology Products and Solutions. Central
Management Group for Consumer, Small & Medium Business Services
Dell International Services India Pvt.Lt
Secondary
India
ISO 9001:2008
The Design, Development and Supporting Functions Of Computers And Technology Products And Services.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
STATE
Scope
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
Dell International Services India,
Secondary
Dell International Services India,
COMPANY
Country
Scheme
Uttar Pradesh
India
ISO 9001:2008
The provision of infrastructure ITO services at the Noida Service Center.
Secondary
Karnataka
India
ISO 9001:2008
The provision of infrastructure ITO services at the Bangalore Service Center.
Dell International Services India,
Secondary
Punjab
India
ISO 9001:2008
All Provisions of Customer Service, Support, Sales Operations and Customer Care for Computers, Technology Products and Solutions
Dell International Services India,
Secondary
Andhra Pradesh
India
ISO 9001:2008
All Provisions of Customer Service, Support, Sales and Customer Care for Computers, Technology Products and Solutions
Dell International Services India,
Secondary
Haryana
India
ISO 9001:2008
All Provisions of Customer Service, Support, Sales Operations and Customer Care for Computers, Technology Products and Solutions
Dell International Services S.R.L.
Secondary
Bucharest
Romania
ISO 9001:2008
The provision of infrastructure ITO services at the Bucharest Service Center
Dell Italian Services
Secondary
6 Milano
Italy
ISO 9001:2008
All Provisions of Customer Service, Support, Sales Operations and Customer Care for Computers, Technology Products and SolutionsIncorporates the
Full Range of Dell Services, including: Systems and Applications Managment, Maintenance and Development; Technical and Business Consulting;
Technical Assistance, Support, Service Desk and Call Center ManagmentProduct Support; Education and End User Support
Dell Limerick
Secondary
Limerick
Ireland
ISO 9001:2008
All Provisions of Customer Service, Support, Sales Operations and Customer Care for Computers, Technology Products and Solutions
Dell Marketing L.P.
Secondary
Lincoln
USA
ISO 9001:2008
The provision of infrastructure information technology outsourcing services at the Lincoln Service Center.
Dell Marketing L.P.
Secondary
Chennai, Tamil Nadu
India
ISO 9001:2008
The provision of infrastructure ITO services at the Chennai Service Center.
Dell Marketing L.P. - DELL
Secondary
Round Rock
TX
USA
ISO 9001:2008
Software design, development and support.
Dell Mobility Products
Primary
Round Rock
TX
USA
TL 9000 R5.0/5.0
TL 9000-HSV Scope: The design, development and customer support service of complex wireless subscriber user terminals (Product Category 6.2.1.2.2
Complex Wireless Subscriber User Terminals)9K Scope: The design, development and customer support service of complex wireless subscriber user
terminals
Dell Mobility Products
Secondary
Santa Clara
CA
USA
TL 9000 R5.0/5.0
TL 9000-HSV Scope: The design, development and customer support service of complex wireless subscriber user terminals (Product Category 6.2.1.2.2
Complex Wireless Subscriber User Terminals)9K Scope: The design, development and customer support service of complex wireless subscriber user
terminals
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
STATE
NE
Scope
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
COMPANY
Profile
Type
CITY
STATE
Country
Scheme
Scope
Belgium
ISO 9001:2008
All Provisions of Customer Service and Support, Sales Operations and Customer Care for Computers, Technology Products and Solutions.
Dell N.V.
Secondary
Dell New Zealand Limited
Secondary
Auckland
New Zealand
ISO 9001:2008
Sales, Sales Operations, Customer Service and Support for a range of desktop, server and notebook computers and associated peripherals.
DELL Products (Poland) Sp. z o.o.
Secondary
92-410 Lodz
Poland
ISO 9001:2008
The manufacture and supply of computer and related products and solutions in EMFP (European Manufacturing Facilty Poland)
Dell Products (Poland) Sp. z o.o.
Secondary
Lodz
Poland
ISO 14001:2004
The manufacture and supply of computer and related products and solutions.
Dell Products (Poland) Sp. z o.o.
Secondary
Poland
OHSAS 18001:2007
The manufacture and supply of computer and related products and solutions.
Dell S.A (Greece)
Secondary
Athens
Greece
ISO 9001:2008
All Provisions of Customer Service, Support, Sales Operations and Customer Care for Computers, Technology Products and Solutions
Dell S.A. (France)
Secondary
Montpellier - 34000
France
ISO 9001:2008
All Provisions of Customer Service, Support, Sales Operations and Customer Care for Computers, Technology Products and Solutions
Dell s.r.o
Secondary
Bratislava
Slovak Republic
ISO 9001:2008
All Provisions of Customer Service, Support, Sales Operations and Customer Care for Computers, Technology Products and Solutions.Includes General
Procurement and Finance Functions.
Dell SA
Secondary
1215 Genève 15
Switzerland
ISO 9001:2008
All Provisions of Customer Service, Support, Sales Operations and Customer Care for Computers, Technology Products and Solutions
Dell SAS
Secondary
20270 Casablanca
Morocco
ISO 9001:2008
All Provisions of Customer Service, Support, Sales Operations and Customer Care for Computers, Technology Products and Solutions
Dell Services - Insurance Services
Secondary
Lincoln
NE
USA
ISO 9001:2008
Dell Insurance Services provides back office policy administration, new business issue, call center support and ancillary services on behalf insurance
company clients as well as provide customer application enhancement programs and projects.
Dell Services - Insurance Services
Secondary
Omaha
NE
USA
ISO 9001:2008
Dell Insurance Services provides back office policy administration, new business issue, call center support and ancillary services on behalf insurance
company clients as well as provide customer application enhancement programs and projects.
Dell Technology & Solutions Israel Ltd
Secondary
Herzliya Pituach
Israel
ISO 9001:2008
The Design and Development of Storage Systems and Solutions
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
Single
Santa Clara
CA
USA
ISO 14001:2004
Product Development
Dell, Inc.
Secondary
Oklahoma City
OK
USA
ISO 9001:2008
All Provisions of Customer Service, Support, Sales Operations and Customer Care for Computers, Technology Products and Solutions
Dell, Inc.
Secondary
Costa Rica S.A.
ISO 9001:2008
Technical Support
Dell, Inc.
Secondary
Nashua
NH
USA
ISO 9001:2008
Research, Design and Development of Storage Systems and Supporting Functions.
Dell, Inc.
Secondary
Atlanta
GA
USA
ISO 9001:2008
Providers of IT Managed Security and Consultancy Services
Dell, Inc.
Secondary
Providence
RI
USA
ISO 9001:2008
Providers of IT Managed Security and Consultancy Services
Dell, Inc.
Primary
Round Rock
TX
USA
ISO 14001:2004
The Development, Manufacture, Supply, and Takeback Services of Computers and Technology Products.
Dell, Inc.
Primary
Round Rock
TX
USA
OHSAS 18001:2007
Device Technologies, Inc.
Single
Southborough
MA
USA
AS 9100 - C
DEX Corporation Northeast
Single
Groveport
OH
USA
ISO 9001:2008
diaDexus, Inc.
Single
South San Francisco
CA
USA
EN ISO 13485:2012
Direct Flow Medical
Secondary
Lake Forest
CA
USA
ISO 13485:2003
Direct Flow Medical
Primary
Santa Rosa
CA
USA
I.S.EN ISO13485:2003
COMPANY
Dell Wyse
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Scope
The Manufacture and Supply of Computers and Technology Products
The Design, Manufacture and Distribution of Specialty Fasteners & Protection Materials, Mechanical Components, Cable Management Materials &
Devices and Linear Polymer Dielectric Services
A Provider of Product Returns, Testing and Repair Solutions for a Wide Variety of Customers and Industries.
Design, manufacture and distribution of In-Vitro diagnostic reagents for the determination and evaluation of cardiovascular biomarkers.
The Design, manufacture, and distribution of Percutaneous Aortic Heart Valves, and associated delivery systems
Design, manufacture, and distribution of percutaneous aortic heart valve and delivery system
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
Dolphin Press
Single
South San Francisco
CA
USA
ISO 9001:2008
DONGGUAN MEADVILLE CIRCUITS LIMITED
Single
Guangdong
China
ECCB HSPM
Manufacture of double-sided and multilayer printed circuit boards.
Dongguan WKK Electronics Co. LTD.
Single
Guangdong Province,
China
AS 9100 - C
The Manufacture of Relay Panel Printed Circuit Board Assemblies. Exclusions: Product Design and Development and Post Delivery support (Service
Operations)
Dow Corning Alabama, Inc.
Single
Mt. Meigs
AL
USA
ISO 9001:2008
The Manufacture of Silicon Metal, Chemical Grade: Primary Aluminum Grade and Secondary Aluminum Grade.
DRA Component Services Inc.
Single
Lawrence
MA
USA
ISO 9001:2008
The provision of device programming, tape and reeling, parametric and functional testing and environmental screening of electronic components.
DRS Power Technology, Inc.
Single
Fitchburg
MA
USA
AS 9100 - C
DRT Medical LLC
Single
Dayton
OH
USA
EN ISO 13485:2012
Duke Energy Renewable Service
Single
Canby
MN
USA
ISO 14001:2004
The provision of technical services, including project operations and maintenance activities to the North American wind industry.
Duke Energy Renewable Service
Single
Canby
MN
USA
ISO 9001:2008
The provision of technical services, including project operations and maintenance activities to the North American wind industry.
Duke Energy Renewable Service
Single
Canby
MN
USA
OHSAS 18001:2007
The provision of technical services, including project operations and maintenance activities to the North American wind industry.
Dunn Industries, Inc.
Single
Manchester
NH
USA
ISO 9001:2008
The custom extrusion of precision small diameter thermoplastic tubing for the medical device industry and other exacting commercial applications.
Eagle Stainless & Tube Fabrication, Inc
Secondary
Franklin
MA
USA
ISO 13485:2003
Distribution, fabrication and assembly of metal and plastic components for the medical device industry.
Eagle Stainless Tube & Fabrication, Inc.
Secondary
Franklin
MA
USA
AS 9100 - C
COMPANY
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Scope
Manufacture of Labels for Packaging Industry
AS9100C Scope: Design, Engineering and Manufacturing of Gas Turbine Packaging, Steam Turbine and Permanent Magnet Electric Motors and
Generators for Naval, Marine, Military Vehicles, Oil, Gas and Power Generator Applications.ISO 9001:2008 Scope: Design, Engineering and
Manufacturing of Gas Turbine Packaging, Steam Turbine and Permanent magnet Electric Motors and Generators for Naval, Marine, Military Vehicles, Oil,
Gas and Power Generation Applications.
Precision Manufacturing of Medical Implants, Medical Instruments, Medical Components and Devices for the Orthopedic Industry.
The distribution, fabrication and assembly of Stainless Steel components and other metals such as Aluminum, Titanium and Copper.Site Specific Activity:
Warehouse
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
Eagle Stainless Tube & Fabrication, Inc.
Primary
Franklin
MA
USA
AS 9100 - C
Eagle Stainless Tube & Fabrication, Inc.
Single
Franklin
MA
USA
ISO 13485:2003
East Coast Microwave
Single
Woburn
MA
USA
AS 9100 - C
Eaton B-Line Business - Wright Line
Single
Worcester
MA
USA
ISO 9001:2008
Design, Manufacture, Distribute, Install and Service Consoles and Enclosures for Data Centers, Control Rooms, Network Operations Centers, 911
Dispatch Centers, and Professional Office Settings.
Primary
Raleigh
NC
USA
ISO 9001:2008
The design, manufacture, delivery, depot repair and support of power quality products and systems for the computer and telecommunications markets.
Eaton Power Quality Operations
Secondary
Youngsville
NC
USA
ISO 9001:2008
The design, manufacture, delivery, depot repair and support of power quality products and systems for the computer and telecommunications markets.
Eaton Power Quality Operations
Secondary
Raleigh
NC
USA
ISO 9001:2008
The design, manufacture, delivery, depot repair and support of power quality products and systems for the computer and telecommunications markets.
Eaton Power Quality Operations
Secondary
Raleigh
NC
USA
ISO 9001:2008
The design, manufacture, delivery, depot repair and support of power quality products and systems for the computer and telecommunications markets.
eBioscience, Inc.
Secondary
San Diego
CA
USA
EN ISO 13485:2012
The Design, Manufacture and Distribution of Immunological Reagents, Including Antibodies and Reagents for Flow Cytometry in the Fields of Immunology
and Oncology.
eBioscience, Inc.
Primary
San Diego
CA
USA
EN ISO 13485:2012
The Design, Manufacture and Distribution of Immunological Reagents, Including Antibodies and Reagents for Flow Cytometry in the Fields of Immunology
and Oncology.
EDO Western Corporation
Single
Salt Lake City
UT
USA
ISO 9001:2008
The design and manufacture of piezoelectric ceramic for the military, medical, automotive, geophysical and ultrasonic industries. Transducer and
hydrophone array design and manufacture for military and commercial applications.
Electronic Components, Inc.
Single
Framingham
MA
USA
AS 9120:2009
THE SOURCING, COUNTERFEIT MITIGATION AND DISTRIBUTION OF ELECTRONIC AND ELECTRO-MECHANICAL PRODUCTS.
Emhart Glass Manufacturing Inc.
Single
Elmira
NY
USA
ISO 9001:2008
The Manufacture of Capital Equipment Used for the Inspection and Handling of Glass Containers.
COMPANY
Eaton Corporation
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Scope
The distribution, fabrication and assembly of Stainless Steel components and other metals such as Aluminum, Titanium and Copper.
Distribution, fabrication and assembly of metal and plastic components for the medical device industry.
Distribution and assembly of RF Microwave components, connectors, and cable assemblies.
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
Single
Owensville
MO
USA
ISO 9001:2008
Endologix, Inc
Secondary
Irvine
CA
USA
EN ISO 13485:2012
The Design and Development, Manufacture and Distribution of Vascular Prostheses and Peripheral Catheters.
Endologix, Inc.
Primary
Irvine
CA
USA
EN ISO 13485:2012
The Design and Development, Manufacture and Distribution of Vascular Prostheses and Peripheral Catheters.
Endologix, Inc.
Secondary
Irvine
CA
USA
EN ISO 13485:2012
The Design and Development, Manufacture and Distribution of Vascular Prostheses and Peripheral Catheters.
Endologix, Inc.
Secondary
Irvine
CA
USA
EN ISO 13485:2012
The Design and Development, Manufacture and Distribution of Vascular Prostheses and Peripheral Catheters.
Endologix, Inc.
Secondary
Irvine
CA
USA
EN ISO 13485:2012
The Design and Development, Manufacture and Distribution of Vascular Prostheses and Peripheral Catheters.
EnerSys
Single
Cleveland
OH
USA
ISO 9001:2008
The design and manufacture of battery charging systems.
EnerSys
Primary
Richmond
KY
USA
ISO 9001:2008
Manufacturing and distribution of lead acid batteries and associated parts.
EnerSys
Single
Hays
KS
USA
ISO 9001:2008
The manufacture of lead acid batteries and accessories.
EnerSys
Single
Hays
KS
USA
ISO 14001:2004
The manufacture of lead acid batteries and accessories.
EnerSys
Single
Tijuana B.C.
Mexico
ISO 9001:2008
The manufacture of sealed lead acid batteries.
EnerSys
Single
Reading
USA
TL 9000 R5.0 /R4.5
EnerSys
Primary
Newport, Gwent Wales
United Kingdom
ISO 9001:2008
COMPANY
Emhart Glass Manufacturing Inc.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
PA
Scope
The Manufacture of Capital Equipment and Parts used in the Manufacture of Glass Products and Containers to Control and Equalize the Temperature of
Molten Glass.
TL9000-H Scope: The design and manufacture of Reserve Power Products FTA, FTC, GC, GU, SBS, VF and M Series batteries installed in telecom
applications for specific telecom customers, in the following reporting categories: 5.3 Power Systems.ISO 9001:2008 Scope: The design, manufacture and
service of batteries, chargers and accessories.
The design and manufacture of sealed lead acid batteries
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
EnerSys
Primary
EnerSys
COMPANY
Country
Scheme
Gwent
United Kingdom
ISO 14001:2004
The design and manufacture of sealed lead acid batteries.
Secondary
Newport
United Kingdom
ISO 9001:2008
The design and manufacture of sealed lead acid batteries
EnerSys
Secondary
Newport
United Kingdom
ISO 14001:2004
The design and manufacture of sealed lead acid batteries
EnerSys
Secondary
Richmond
KY
USA
ISO 9001:2008
Manufacturing and distribution of lead acid batteries and associated parts.
EnerSys
Secondary
Richmond
KY
USA
ISO 9001:2008
Manufacturing and distribution of lead acid batteries and associated parts.
Single
Horsham
PA
USA
ISO 9001:2008
The design, development and manufacture of lithium ambient temperature, lithium thermal and lithium ion battery products for the defense and
telecommunications industries.
ENERSYS DE MEXICO S. DE R.L. DE C.V.
Secondary
Apodaca, N.L.
Mexico
ISO 9001:2008
The Manufacture and Sales of Industrial Lead-Acid Batteries and Fabrication of Metal Trays.
ENERSYS DE MEXICO S. DE R.L. DE C.V.
Primary
N.L.
Mexico
ISO 9001:2008
The Manufacture and Sales of Industrial Lead-Acid Batteries and Fabrication of Metal Trays.
EnerSys Delaware Inc.
Single
Sumter
SC
USA
ISO 9001:2008
The Manufacture of Steel Trays.
EnerSys Energy Products
Single
Warrensburg
MO
USA
ISO 9001:2008
The design and manufacture of lead acid batteries.
EnerSys Energy Products, Inc.
Single
Warrensburg
MO
USA
ISO 14001:2004
The design and manufacture of lead acid batteries
EnerSys S.A.R.L.
Single
Cedex
France
ISO 9001:2008
Design, Development, Production, Sales and Servicing of Lead Acid Technology Industrial Batteries and power chargers.
EnerSys S.A.R.L.
Single
Cedex
France
ISO 14001:2004
Manufacturing of lead acid technology industrial batteries and (battery) chargers.Fabrication de batteries Industrielles de Technologie Plomb/Acide et de
chargeurs.
EnerSys Advanced Systems
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
STATE
Scope
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
EnerSys S.r.l.
Single
Gambellara (VI)
EnerSys S.R.O.
COMPANY
Country
Scheme
Italy
ISO 9001:2008
Manufacture, sale and installation of traction, stationary, special use batteries and accessories.
Single
Czech Republic
ISO 14001:2004
Design, Development, Production, Sales and Service of Industrial and ATEX Batteries and their Accessories. Sales and Service of Reserve Power
Supplies. Production of Trays for Industrial Batteries.
EnerSys s.r.o.
Secondary
Slovenská republika
ISO 9001:2008
Production, sales and service of industrial batteries and their accessories. Sales and service of reserve power supplies. Production of trays for industrial
batteries
EnerSys s.r.o.
Secondary
Ceská republika
ISO 9001:2008
Production, sales and service of industrial batteries and their accessories. Sales and service of reserve power supplies. Production of trays for industrial
batteries
EnerSys s.r.o.
Primary
Czech republika
ISO 9001:2008
Production, sales and service of industrial batteries and their accessories. Sales and service of reserve power supplies. Production of trays for industrial
batteriesOsvedcení o registraci
EnerSys s.r.o.
Single
Czech Republic
ISO 14001:2004
Design, Development, Production, Sales and Service of Industrial and ATEX Batteries and their Accessories. Sales and Service of Reserve Power
Supplies. Production of Trays for Industrial Batteries.
EnerSys Sp. z o.o.
Single
43-300 Bielsko-Biala
Poland
ISO 9001:2008
Design, Development, Production and Sales of Lead-Acid Cells, Lead-Acid Batteries and Components.
EnerSys Sp. z o.o.
Single
43-300 Bielsko-Biala
Poland
ISO 14001:2004
Design, Development, Production and Sales of Lead-Acid Cells, Lead-Acid Batteries and Components.
EnerSys Sp. z o.o.
Single
43-300 Bielsko-Biala
Poland
OHSAS 18001:2007
Design, Development, Production and Sales of Lead-Acid Cells, Lead-Acid Batteries and Components.
Environmental Reclamation Services, LLC
Single
Erie
PA
USA
ISO 14001:2004
EORM, Inc
Primary
San Jose
CA
USA
OHSAS 18001:2007
Provider of Environmental, Health, Safety and Sustainability Management Systems Consulting Services.
EORM, Inc
Secondary
Laguna Hills
CA
USA
OHSAS 18001:2007
Provider of Environmental, Health, Safety and Sustainability Management Systems Consulting Services.
EORM, Inc
Secondary
Alameda
CA
USA
OHSAS 18001:2007
Provider of Environmental, Health, Safety and Sustainability Management Systems Consulting Services.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
STATE
Scope
Inspection and sale of used laser and inkjet printer cartridges, cellphones and consumer electronic products.
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
EORM, Inc
Secondary
Hillsboro
OR
USA
OHSAS 18001:2007
Provider of Environmental, Health, Safety and Sustainability Management Systems Consulting Services.
EORM, Inc.
Primary
San Jose
CA
USA
ISO 14001:2004
Provider of Environmental, Health, Safety and Sustainability Management Systems Consulting Services.
EORM, Inc.
Secondary
Laguna Hills
CA
USA
ISO 14001:2004
Provider of Environmental, Health, Safety and Sustainability Management Systems Consulting Services.
EORM, Inc.
Secondary
Alameda
CA
USA
ISO 14001:2004
Provider of Environmental, Health, Safety and Sustainability Management Systems Consulting Services.
EORM, Inc.
Secondary
Hillsboro
OR
USA
ISO 14001:2004
Provider of Environmental, Health, Safety and Sustainability Management Systems Consulting Services.
COMPANY
Scope
Epic Medical Concepts & Innovations
Secondary
Grain Valley
MO
USA
EN ISO 13485:2012
13485 Scope: Contract and proprietary design and development, manufacturing, distribution and servicing of active medical systems for neurological
diagnostics, active and non-active surgical instruments and suction catheters for plastic, orthopedic,thoracic and general surgery. 9k Scope:Design,
development, manufacturing, distribution and servicing of active and non-active diagnostic and therapeutic medical devices and surgical instruments for
plastic, orthopedic and general surgery; Metalfinishing and engraving services for Industrial and Medical applications.
Epic Medical Concepts & Innovations
Primary
Mission
KS
USA
EN ISO 13485:2012
13485 Scope: Contract and proprietary design and development, manufacturing, distribution and servicing of active medical systems for neurological
diagnostics, active and non-active surgical instruments and suction catheters for plastic, orthopedic,thoracic and general surgery. 9k Scope:Design,
development, manufacturing, distribution and servicing of active and non-active diagnostic and therapeutic medical devices and surgical instruments for
plastic, orthopedic and general surgery; Metalfinishing and engraving services for Industrial and Medical applications.
ErgoMet Inc
Single
Ward Hill
MA
USA
ISO 9001:2008
Excelitas Canada Inc.
Single
Quebec
Canada
OHSAS 18001:2007
Design, manufacturing and test of optoelectronic devices.
Excelitas Canada Inc.
Single
Quebec
Canada
ISO 9001:2008
Design, manufacturing and test of optoelectronic devices.
Excelitas Canada Inc.
Single
Quebec
Canada
ISO 14001:2004
The Design, Manufacturing and Test of Optoelectronic Devices.
Excelitas Technologies (Shenzhen)
Single
Shenzhen
China
ISO 9001:2008
Design and Manufacture of Flash Lamps, Photocells and Solid State Lighting Products.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Manufacturing of Precision Sheet Metal parts and assemblies for diverse industries, including medical.
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
Excelitas Technologies (Shenzhen)
Single
Excelitas Technologies (Shenzhen)
COMPANY
Country
Scheme
Shenzhen
China
ISO 14001:2004
Design and Manufacture of Flash Lamps, Photocells and Solid State Lighting Products.
Single
Shenzhen
China
OHSAS 18001:2007
Design and Manufacture of Flash Lamps, Photocells and Solid State Lighting Products.
Excelitas Technologies Corp.
Single
Covina
CA
USA
AS 9100 - C
Excelitas Technologies Corp.
Single
Miamisburg
OH
USA
OHSAS 18001:2007
Design and manufacture of electro-optic components, energetic devices and electronic safe and arm devices.
Excelitas Technologies Corp.
Single
Covina
CA
USA
OHSAS 18001:2007
The design, manufacture and servicing of power supplies, power conditioning devices, and optoelectronic systems
Excelitas Technologies Corporation
Single
Salem
MA
USA
ISO 9001:2008
The design and manufacture of electro-optical components, high energy switches, medical component, time frequency standards, high voltage power
conversion systems and X-ray sources.
Excelitas Technologies Corporation
Single
Fremont
CA
USA
EN ISO 13485:2012
ISO 13485 Scope: The design and development, manufacture and distribution of electrical lamps, lamp modules and power supplies including system
integration and testing for the medical device industry.ISO 9001 Scope: Designs, develops, manufactures and distributes specialty lamps, lighting
equipment and power supplies for the medical, industrial, communication, aerospace, scientific, entertainment and military markets.
Excelitas Technologies Elcos GmbH
Single
Germany
ISO 9001:2008
Excelitas Technologies Elcos GmbH
Single
Germany
OHSAS 18001:2007
Excelitas Technologies GmbH & Co.KG
Single
Wiesbaden
Germany
ISO 9001:2008
Design and Distribution of Optoelectronic Products.
Excelitas Technologies GmbH & Co.KG
Single
Wiesbaden
Germany
OHSAS 18001:2007
Design and Distribution of Optoelectronic Products.
Excelitas Technologies Inc.
Single
Fremont
CA
USA
ISO 14001:2004
Design, Development, Manufacture and Distribution of Specialty Lamps and Lighting Equipment for the Medical, Industrial, Communication, Aerospace,
Scientific, Entertainment and Military Markets.
Excelitas Technologies Inc.
Single
Salem
MA
USA
ISO 14001:2004
The design and manufacture of electro-optical components, high energy switches, medical component, time frequency standards, high voltage power
conversion systems and X-ray sources.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
STATE
Scope
The design, manufacture and servicing of power supplies, power conditioning devices and optoelectronic systems.
Development, manufacturing and distribution of optoelectronics components.
Development, manufacturing and sales of optoelectronic components.
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
Excelitas Technologies Inc.
Single
Salem
MA
USA
OHSAS 18001:2007
The design and manufacture of electro-optical components, high energy switches, medical component, time frequency standards, high voltage power
conversion systems and X-ray sources.
Excelitas Technologies Inc.
Secondary
Fremont
CA
USA
OHSAS 18001:2007
Design, Development, Manufacture and Distribution of Specialty Lamps and Lighting Equipment for the Medical, Industrial, Communication, Aerospace,
Scientific, Entertainment and Military Markets.
Excelitas Technologies Inc.
Single
Wheeling
IL
USA
EN ISO 13485:2012
MD Scope: The design, manufacture and contract development of LED electrical lamps and lamp modules for the medical device industry.ISO9K Scope:
Design and manufacture of LED based lighting solutions
Excelitas Technologies Philippines, Inc.
Single
Laguna
Philippines
ISO 14001:2004
Manufacture and Test of Optoelectronic Components and Assemblies.
Excelitas Technologies Philippines, Inc.
Single
Laguna
Philippines
OHSAS 18001:2007
Manufacture and Test of Optoelectronic Components and Assemblies.
Excelitas Technologies Philippines, Inc.
Single
Laguna
Philippines
ISO 9001:2008
Manufacture and Test of Optoelectronic Components and Assemblies.
Excelitas Technologies Sensors, Inc
Single
Covina
CA
USA
ISO 14001:2004
The design, manufacture and servicing of power supplies, power conditioning devices and optoelectronic systems.
Excelitas Technologies Sensors, Inc.
Single
Miamisburg
OH
USA
ISO 9001:2008
Design and Manufacturing of Energetic Components used for DOD, DOE and commercial applications.
Singapore
ISO 9001:2008
Design and Manufacture of Optoelectronics Products
The Design, Development and Manufacture of Chemicals, Polymers, and Pharmaceutical Intermediates.
COMPANY
Excelitas Technologies Singapore Pte Ltd
Secondary
Far Research Inc.
Single
Palm Bay
FL
USA
ISO 9001:2008
FastForm Research Ltd
Single
Killowen
Co.
Waterford
Ireland
EN ISO 13485:2012
Fiberoptic Components, LLC
Single
Sterling
MA
USA
ISO 13485:2003
Filtertek
Single
Co. Limerick
Ireland
EN ISO 13485:2012
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Scope
The design, development and manufacture of medical devices for orthopaedic and soft-tissue splinting and support.
ISO 13485:2003 Scope: The Design and Manufacture of Fiber Optic Cable, Components and Sub Assemblies for the Medical Device Industry.ISO
9001:2008 Scope: The Design and Manufacture of Fiber Optic Cable, Components and Sub Assemblies for the Commercial and Medical Device Industry.
ISO 13485 Scope: The design, manufacture and packaging of sterile and non-sterile plastic moulded products, filters and valves for the medical device
industry.ISO 9001 Scope: The design and manufacture of specialised plastic moulded products, filters and valves for the commercial, automotive and
industrial markets.
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
First State Mfg.
Single
Milford
DE
USA
AS 9100 - C
Fluidmaster Water Technology
Single
Guadalupe, N.L.
Mexico
ISO 9001:2008
The manufacture and assembler of toilet trim and proprietary plumbing products.
Fluidmaster, Inc.
Single
San Juan Capistrano
CA
USA
ISO 9001:2008
The design, pilot production, sales and supply chain management of toilet trim and proprietary plumbing products.
FMC BioPolymer
Single
Newark
DE
USA
ISO 9001:2008
The manufacture of excipients for the food and pharmaceutical industries.
Foam Pack/Future Pack
Single
San Juan
PR
Puerto Rico
ISO 9001:2008
The manufacture of corrugated and foam packaging.
Focal Therapeutics
Single
Portola Valley
CA
USA
EN ISO 13485:2012
Secondary
Chennai, Tamil Nadu
600 032
India
ISO 9001:2008
Foresight Imaging, LLC
Single
Chelmsford
MA
USA
EN ISO 13485:2012
Freedom USA, Inc.
Single
Twinsburg
OH
USA
ISO 9001:2008
Fugang Electric (Kunshan) Co., Ltd.
Single
Jiang Su Province
China
TL 9000 R5.0 /R4.5
TL9000-H Scope: Manufacture and Sales of Communication Products and Semi-Products such as Mobile Phone, Blue Tooth, PND (Personal Navigation
Device) Accessoriesfor the Following Product Category: 7.7.4 Electromechanical AssemblyISO9K Scope: Manufacture and Sales of Communication
Products and Semi-Products such as Mobile Phone, Blue Tooth, PND (Personal Navigation Device) Accessories
G&F Medical, Inc.
Single
Danvers
MA
USA
EN ISO 13485:2012
MD Scope: The Manufacture of Injection Molded Components for the Medical Device Industry.ISO9K Scope: The Manufacture of Injection Molded Parts.
G.E. Mathis Company
Secondary
Chicago
IL
USA
ISO 9001:2008
Manufacture of general steel fabrications and assemblies for, but not limited to, industries such as; agricultural equipment, chemical container,
construction equipment, energy and mining.
G.E. Mathis Company
Secondary
Chicago
IL
USA
ISO 9001:2008
Manufacture of general steel fabrications and assemblies for, but not limited to, industries such as; agricultural equipment, chemical container,
construction equipment, energy and mining.
COMPANY
Force 10 Networks India Pvt. Ltd.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Scope
AS9100: Manufacture of Custom Sewn & Upholstered products for the Aerospace Industry.
The design, manufacture and distribution of bioabsorbable radiopaque tissue markers, and associated accessories.
The design, development and supporting functions for networking products and services.
ISO 13485: The design, manufacture, sales and service of video imaging boards, systems and software for medical markets.ISO 9001: The design,
manufacture, sales and service of video imaging boards, systems and software for medical and industrial markets.
Internet processing of custom hardware and software solutions, assembly, repair and consulting services for one stop shop end users.
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
Primary
Chicago
IL
USA
ISO 9001:2008
Garmin AT
Secondary
Salem
OR
USA
AS 9100 - C
Design, Manufacture, Certification, Distribution, and Support of Navigation, Communication, and Flight Control Equipment for Aerospace Applications.
Garmin AT
Secondary
Salem
OR
USA
ISO 9001:2008
Design, manufacture, distribution and support of navigation, communication and information devices with applications for aerospace, marine, outdoor
recreation, automotive, wireless and OEM markets.
Garmin International
Secondary
New Century
KS
USA
AS 9100 - C
Garmin International
Secondary
Olathe
KS
USA
ISO 9001:2008
Call Center in support of navigation, communication, and information devices with applications for aerospace, marine, outdoor recreation, automotive,
wireless and OEM markets
Garmin International
Secondary
Kansas City
MO
USA
ISO 9001:2008
Call Center in support of navigation, communication, and information devices with applications for aerospace, marine, outdoor recreation, automotive,
wireless and OEM markets
Garmin International
Secondary
Salem
OR
USA
ISO 9001:2008
Design, manufacture, distribution and support of navigation, communication and information devices with applications for aerospace, marine, outdoor
recreation, automotive, wireless and OEM markets.
Garmin International
Primary
Olathe
KS
USA
ISO 9001:2008
Design, manufacture, distribution, and support of navigation, communication, and information devices with applications for aerospace, marine, outdoor
recreation, automotive, wireless and OEM markets.
Garmin International
Primary
Olathe
KS
USA
AS 9100 - C
Garmin International
Primary
Olathe
KS
USA
ISO 14001:2004
Design, Manufacture, Distribution and Support of Navigation, Communication, and Information Devices with Applications for Aerospace, Marine, Outdoor
Recreation, Automotive, Wireless and OEM Markets.
Garmin International
Secondary
New Century
KS
USA
ISO 14001:2004
Design, Manufacture, Distribution and Support of Navigation, Communication, and Information Devices with Applications for Aerospace, Marine, Outdoor
Recreation, Automotive, Wireless and OEM Markets.
GatesAir
Secondary
Quincy
IL
USA
ISO 9001:2008
The Design, Manufacture, Sales and Service of Radio, Television, and Networking products for use in Broadcast Communications and related media
industries.
GatesAir
Primary
Mason
OH
USA
ISO 9001:2008
The Design, Manufacture, Sales and Service of Radio, Television, and Networking products for use in Broadcast Communications and related media
industries.
COMPANY
G.E. Mathis Company
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Scope
Manufacture of general steel fabrications and assemblies for, but not limited to, industries such as; agricultural equipment, chemical container,
construction equipment, energy and mining.
Flight Operations center performing Design and Certification activities in support of Navigation, Communication, and Flight Control Equipment for
Aerospace Applications
AS9100 Scope: Design, Manufacture, Certification, Distribution, and Support of Navigation, Communication, and Flight Control Equipment for Aerospace
Applications.ISO 9001:2008 Scope: Design, manufacture, distribution, and support of navigation, communication and information devices with applications
for aerospace, marine, outdoor recreation, automotive, wireless and OEM markets
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
GatesAir
Single
Quincy
IL
USA
OHSAS 18001:2007
The Design, Manufacture, Sales and Service of Radio, Television, and Networking products for use in Broadcast Communications and related media
industries.
GatesAir
Single
Quincy
IL
USA
ISO 14001:2004
The Design, Manufacture, Sales and Service of Radio, Television, and Networking products for use in Broadcast Communications and related media
industries.
Secondary
D-08056 Zwickau
Germany
ISO 9001:2008
Development, production and sales of industrial batteries and aircraft NiCd batteries and accessories.
Gemini Technical Services, Inc.
Single
Bow
NH
USA
ISO 9001:2008
Repair of Printed Circuit Boards and Associated Assemblies
General Dynamics Global Imaging Tech.
Single
Cullman
AL
USA
AS 9100 - C
COMPANY
GAZ GmbH
Scope
The Ultra-Precision Machining of Beryllium, Conventional and other Exotic Materials and the Design, Development, Production and Assembly of Optical
Components such as Lenses, Filters, Mirrors and Telescopes.
Biocompatibility, microbiological, chemical, electronic, safety, and toxicological testing utilizing applicable International and U.S. standards for a variety of
medical device, supplies, laboratory and diagnostic products. Chemical and electrical testing of electronic components and assemblies used in
instruments. Tests include: Gram Stain, Ames Test, Hemolysis Test, Cytotoxicity Assay, Antimicrobial Effectiveness Test, Microbial Limits, Bacterial
Endotoxin, Particle Count, Package Integrity, Sterility, Bioburden, Physico-chemical Test, Intracutaneous Test, Acute Systemic Toxicity Test, Ocular
Irritation Test, Penile Mucosa Irritation Test, Closed Patch Sensitization, Dermal Sensitization, Intramuscular Implantation Test, Oral Mucosa Irritation,
Vaginal Mucosa Irritation, Primary Skin Irritation, and Muscle Implantation Test.
Geneva Laboratories
Single
Elkhorn
WI
USA
IECQ ITL
Geneva Laboratories
Single
Elkhorn
WI
USA
ISO 9001:2008
Biocompatibility, microbiological, chemical, electronic, safety, and toxicological testing utilizing applicable International and U.S. standards for a variety of
medical device, supplies, laboratory and diagnostic products. Chemical and electricaltesting of electronic components and assemblies used in instruments.
GIT Satellite LLC
Single
Austin
TX
USA
ISO 14001:2004
Provider of Satellite Communication Products and Services. Design, Development and Manufacturing of Satellite Communications Equipment.
GIT Satellite LLC
Single
Austin
TX
USA
ISO 9001:2008
Provider of Satellite Communication Products and Services. Design, Development and Manufacturing of Satellite Communications Equipment.
Global Instrumentation LLC
Single
Manlius
NY
USA
ISO 13485/CMDCAS
Globaltek Components LLC
Single
Milton
NH
USA
ISO 9001:2008
Secondary
Cedex 3
France
ISO 13485/CMDCAS
GRAFTYS
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
The design, development, manufacture, distribution, installation and servicing of Holter Recorder and Analysis Systems for Medical Applications.
Electronic Distributor, Third Party Logistics and Asset Recovery Provider
The Design, Manufacture and Distribution of Sterile Calcium Phosphate Resorbable Bone Void Fillers and related Delivery Systems.
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
GRAFTYS
Secondary
GRAFTYS
COMPANY
Country
Scheme
Cedex 3
France
ISO 13485/CMDCAS
The Design, Manufacture and Distribution of Sterile Calcium Phosphate Resorbable Bone Void Fillers and related Delivery Systems.
Primary
Cedex 3
France
ISO 13485/CMDCAS
The Design, Manufacture and Distribution of Sterile Calcium Phosphate Resorbable Bone Void Fillers and related Delivery Systems.
Greatbatch Beaverton
Single
Beaverton
OR
USA
ISO 13485:2003
ISO9K: Design and manufacture of portable power solutions for electronic devices.MD: Design and manufacture of portable power solutions for medical
devices.
Greatbatch Medical
Single
Plymouth
MN
USA
ISO 13485/CMDCAS
Design and development, manufacture, contract manufacture, and distribution of active implantable medical devices, Implantable Leads for AIMDs and
related accessories, Percutaneous Introducer Systems, Delivery Catheters, Sheaths, Safety Needles andcomponents.
Greatbatch Medical
Secondary
Clarence
NY
USA
EN ISO 13485:2012
The manufacturing and assembly of precision components and sub assemblies for medical devices.
Greatbatch Medical
Primary
Clarence
NY
USA
ISO 9001:2008
The design, manufacture and test of capacitors and lithium batteries for use in implantable medical devices, and lithium ion rechargeable batteries for
medical applications.
Greatbatch Medical
Single
Minneapolis
MN
USA
ISO 9001:2008
The Manufacture of Deep Drawn Device Enclosures, Cases, and Complex Stampings for Implantable Medical Devices and other Commercial Applications.
Greatbatch Medical
Primary
Clarence
NY
USA
EN ISO 13485:2012
The manufacturing and assembly of precision components and sub assemblies for medical devices.
Single
Tijuana, B.C.
Mexico
EN ISO 13485:2003
The Manufacture, Assembly and Testing of Components and Sub-Assemblies for Implantable Medical Devices and other Medical Applications including
Feedthroughs and Filtered Feedthroughs and the Manufacture of non sterile, Acetabular Reamer orthopedicinstruments.
Greatbatch Medical Orthopedics
Secondary
Fort Wayne
IN
USA
ISO 13485/CMDCAS
Design, development, manufacturing, and distribution of orthopaedics and trauma implants, instruments and sterilization cases, trays and lids. (Corporate
Headquarters, and the Sales, Marketing, and Customer Service area for commercial business)
Greatbatch Medical Orthopedics
Secondary
Indianapolis
IN
USA
ISO 13485/CMDCAS
Design, develoment, manufacturing, and distribution of orthopaedics and trauma implants, instruments and sterilization cases, trays and lids. (Corporate
Headquarters, and the Sales, Marketing, and Customer Service area for commercial business)
Greatbatch Medical Orthopedics
Secondary
Chaumont
France
ISO 13485/CMDCAS
Design, development, manufacturing, and distribution of orthopaedics and trauma implants, instruments and sterilization cases, trays and lids. (Corporate
Headquarters, and the Sales, Marketing, and Customer Service area for commercial business)
Greatbatch Medical Orthopedics
Primary
Clarence
USA
ISO 13485/CMDCAS
Design, develoment, manufacturing, and distribution of orthopaedics and trauma implants, instruments and sterilization cases, trays and lids.
Greatbatch Medical Mexico,
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
STATE
NY
Scope
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
Single
Bienne
Greatbatch, Inc.
Secondary
Alden
Greatbatch, Inc.
Primary
Greatbatch, Inc.
COMPANY
Country
Scheme
Switzerland
EN ISO 13485:2012
NY
USA
ISO 9001:2008
Raynham
MA
USA
EN ISO 13485:2012
MD Scope: The design, manufacture, distribution and servicing of non implantable batteries for medical device applications.ISO9K Scope: The Design and
Manufacture of Specialty Lithium Primary and Rechargeable Batteries and Battery Packs.
Secondary
Taunton
MA
USA
EN ISO 13485:2012
MD Scope: The design, manufacture, distribution and servicing of non implantable batteries for medical device applications.ISO9K Scope: The design and
manufacture and specialty lithium primary and rechargeable batteries and battery packs.
GRL EMEA & EMEA Customer Q&R.
Single
Leixlip, County Kildare
Ireland
ISO 9001:2008
The provision of reverse logistics and customer quality and reliability support services for Intel products in the EMEA region.
GStek, Inc.
Single
Chesapeake
VA
USA
ISO 9001:2008
Provisioning of Telecommunications, Information Technology, Program Management, Logistics, Administration, and Engineering support services for
government and commercial contracts.
Guild Optical Associates
Single
Amherst
NH
USA
ISO 9001:2008
The manufacture, including grinding and polishing of windows, lenses and mirrors from glass substrates and sapphire crystal
Hanson Research Corporation
Single
Chatsworth
CA
USA
ISO 9001:2008
The design, manufacture, installation and service of laboratory equipment.
Harbor MedTech
Single
Irvine
CA
USA
ISO 13485/CMDCAS
Design, Manufacture and Distribution of stabilized (equine) collagen matrix products for wound care.
Secondary
Castlerea Co.
Roscommon
Ireland
EN ISO 13485:2012
The Design, Development, Manufacture and Contract Manufacturing of Disposable Medical Devices and Plastic Components Including Catheters, Infusion
Sets for Oncology, Enteral Feeding and Diagnostics and the Contract Manufacturing of Non-ActiveImplantable Medical Devices Including Devices
Containing Tissue of Animal Origin.
Harmac Medical Products, Inc.
Primary
Buffalo
USA
EN ISO 13485:2012
The Design, Development, Manufacture and Contract Manufacturing of Disposable Medical Devices and Plastic Components Including Catheters, Infusion
Sets for Oncology, Enteral Feeding and Diagnostics and the Contract Manufacturing of Non-ActiveImplantable Medical Devices Including Devices
Containing Tissue of Animal Origin.
Harmac Medical Products, Inc.
Secondary
Nueva Tijuana
Mexico
EN ISO 13485:2012
The Design, Development, Manufacture and Contract Manufacturing of Disposable Medical Devices and Plastic Components Including Catheters, Infusion
Sets for Oncology, Enteral Feeding and Diagnostics and the Contract Manufacturing of Non-ActiveImplantable Medical Devices Including Devices
Containing Tissue of Animal Origin.
Single
Peabody
USA
ISO 9001:2008
Greatbatch Medical SA
Harmac Medical Products
Harmonic Drive L.L.C.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
STATE
NY
MA
Scope
The Distribution of Orthopedic Medical Devices
The design, manufacture and test of capacitors and lithium batteries for use in implantable medical devices, and lithium Ion rechargeable batteries for
medical applications.
The design, manufacture and sale of precision gear reducers, servo-actuators and electro-mechanical positioning systems.
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
Harmonic Drive L.L.C.
Single
Peabody
MA
USA
AS 9100 - C
HAWKER GmbH
Single
D-58089 Hagen
Germany
ISO 9001:2008
Development, production and sales of industrial batteries and aircraft NiCd batteries and accessories
HAWKER GmbH
Single
D 58089 Hagen
Germany
ISO 14001:2004
Development, production and sales of industrial batteries and accessories
HAWKER GmbH
Single
D 58089 Hagen
Germany
OHSAS 18001:2007
Development, production and sales of industrial batteries and accessories
Hawker Powersource, Inc.
Single
Ooltewah
TN
USA
ISO 9001:2008
The design and manufacture of industrial batteries.
hcc Aegis
Single
New Bedford
MA
USA
ISO 9001:2008
The Manufacture of High Reliability Hermetic Glass to Metal Seal Packages for the Microelectronics Industry.
HemCon Medical Technologies, Inc.
Single
Portland
OR
USA
ISO 13485/CMDCAS
Hexavision SARL
Single
Paris
France
ISO 13485:2003
The design and development, manufacture and distribution of sterile intraocular lenses.
Hitachi Cable America, Inc.
Single
Manchester
NH
USA
ISO 9001:2008
Drawing and insulation of nonferrous wire. The design and manufacture of copper and fiber optic cable for the telecommunications, data and electronic
markets.
Hollister Incorporated
Single
Stuarts Draft
VA
USA
EN ISO 13485:2012
The manufacture of external use only, sterile and non-sterile, disposable medical devices intended for ostomy, incontinence and wound care.
Hollister Incorporated
Single
Kirksville
MO
USA
EN ISO 13485:2012
The Manufacture of External Use Only, Sterile and Non-sterile, Medical Devices Intended for Ostomy, Incontinence,
Obstetrics/Gynaecology/Newborn/Paediatric and Wound Care Products.
Hollister Incorporated
Primary
Libertyville
IL
USA
ISO 13485/CMDCAS
The Design, Manufacture and Distribution of External and Invasive Use, Sterile and Non-sterile, Disposable Medical Devices Intended for Ostomy,
Incontinence, Wound Care Products and the Contract Manufacture of Sterile and Non-Sterile Obstetrics,Gynecology, Newborn, and Pediatric Products.
Hollister Incorporated
Single
Libertyville
IL
USA
EN ISO 13485:2012
The Management of Manufacturers of Sterile and Non-Sterile External, Invasive, and Disposable Medical Devices Intended for Ostomy, Incontinence, and
Wound Care Products.
COMPANY
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Scope
The design, manufacture and sale of precision gear reducers, servo-actuators and electro-mechanical positioning systems for use in aviation, space and
defense.
The design and manufacture of chitosan-based hemorrhage control wound management devices.
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
COMPANY
Hollister Medical India Private Limited
Hollister Services BV
Profile
Type
CITY
Single
Haryana
STATE
Secondary
Country
Scheme
Scope
India
EN ISO 13485:2012
The Manufacture of Sterile & Non-Sterile Medical Devices for the treatment of Incontinence, including Urinary Intermittent Catheters, Coude Taper Tip
Urinary Intermittent Catheters, Urinary Catheterization Systems, Urinary Catheterization Kits andCatheter Insertion Kits.
The Netherlands
ISO 13485/CMDCAS
The Design, Manufacture and Distribution of External and Invasive Use, Sterile and Non-sterile, Disposable Medical Devices Intended for Ostomy,
Incontinence, Wound Care Products and the Contract Manufacture of Sterile and Non-Sterile Obstetrics,Gynecology, Newborn, and Pediatric Products.
Single
Rehins
Co. Mayo
Ireland
EN ISO 13485:2012
The design, manufacture and distribution of steriile and non-steriile ostomy and urinary continence care prodcuts including catheters, ostomy pouches and
related accessories.
Hospira
Secondary
Pleasant Prairie
WI
USA
ISO 13485/CMDCAS
The Design, Manufacture, Distribution, Refurbishment and Service of electronic drug and enteral infusion devices, medical computer monitoring
equipment, and EEG monitors.The Design, Manufacture and Distribution of custom and standard intravenous administration sets, custom kits, intravenous
cathethers, intravenous monitoring devices, feeding tubes, surgical receptor devices, EEG sensors, and their related accessoriesand molded subassemblies.
Hospira
Secondary
Lake Forest
IL
USA
ISO 13485/CMDCAS
The Design, Manufacture, Distribution, Refurbishment and Service of electronic drug and enteral infusion devices, medical computer monitoring
equipment, and EEG monitors.The Design, Manufacture and Distribution of custom and standard intravenous administration sets, custom kits, intravenous
cathethers, intravenous monitoring devices, feeding tubes, surgical receptor devices, EEG sensors, and their related accessoriesand molded subassemblies.
Hospira
Secondary
Pleasant Prairie
WI
USA
ISO 13485/CMDCAS
The Design, Manufacture, Distribution, Refurbishment and Service of electronic drug and enteral infusion devices, medical computer monitoring
equipment, and EEG monitors.The Design, Manufacture and Distribution of custom and standard intravenous administration sets, custom kits, intravenous
cathethers, intravenous monitoring devices, feeding tubes, surgical receptor devices, EEG sensors, and their related accessoriesand molded subassemblies.
Hospira
Single
Co. Sligo
Ireland
EN ISO 13485:2012
The manufacture, refurbishment, service and distribution of electronic devices for drug infusion and enteral feeding.
Canada
ISO 13485:2003
Hollister ULC
Hospira Canada Service Center
Hospira Costa Rica Ltd.
Hospira HealthCare Corporation - Canada
Hospira Ltd.
Hospira San Diego
Hospira, Inc
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Secondary Saint-Laurent, Québec
The Distribution, Service, Repair and Remanufacture of Electronic Drug Infusion Devices and Spare Parts.
Single
La Aurora de Heredia
Costa Rica
EN ISO 13485:2012
The manufacture of disposable sterile administration sets, infusion pump sets, critical care products, catheter flush syringes and non-sterile
components.The manufacture, remanufacture, repair, service and distribution of electronic infusion devices, spare parts and accessories.
Primary
Saint-Laurent, Quebec
Canada
EN ISO 13485:2012
The Distribution, Service, Repair and Remanufacture of Electronic Drug Infusion Devices and Spare Parts.
Single
Itabo, Haina, San
Cristobal
Dominican Republic
EN ISO 13485:2012
The manufacture of sterile administration sets, feeding systems and non-sterile surgical receptor devices.
Secondary
San Diego
USA
ISO 13485/CMDCAS
The design and development of systems software for Hospira infusion pumps.
ISO 13485/CMDCAS
The Design, Manufacture, Distribution, Refurbishment and Service of electronic drug and enteral infusion devices, medical computer monitoring
equipment, and EEG monitors.The Design, Manufacture and Distribution of custom and standard intravenous administration sets, custom kits, intravenous
cathethers, catheter flush syringes, intravenous monitoring devices, feeding tubes, surgical receptor devices, EEG sensors,and their related
accessoriesand molded sub-assemblies.
Primary
Lake Forest
CA
IL
USA
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
Scope
Hospira, Inc.
Single
San Jose
CA
USA
EN ISO 13485:2012
The Remanufacture, Repair, Service and Distribution of Electronic Drug Infusion Devices and Packaging and Distribution of Accessories Including Medical
Software.
Hospira, Inc.
Single
Rocky Mount
NC
USA
EN ISO 13485:2012
The Provision of Irradiation Sterilization Services and Contract Irradiation Sterilization Services for Medical Devices in Accordance with ISO 11137-1:2006
Houck Machine Company
Single
Plymouth
MN
USA
ISO 9001:2008
Howard Instruments II, Inc.
Single
Tuscaloosa
AL
USA
EN ISO 13485:2012
Hutchinson Technology Inc.
Primary
Hutchinson
MN
USA
ISO 9001:2008
The design, development and manufacture of rigid disk drive components.
Hutchinson Technology Inc.
Secondary
Eau Claire
WI
USA
ISO 9001:2008
The design, development and manufacture of rigid disk drive components.
Hutchinson Technology Inc.
Secondary
Plymouth
MN
USA
ISO 9001:2008
The design, development and manufacture of rigid disk drive components.
Hydroid, Inc
Single
Pocasset
MA
USA
ISO 14001:2004
The Design, Software Development, Manufacture, Sales and Service of Marine Robotic Systems.
Hydroid, Inc
Single
Pocasset
MA
USA
OHSAS 18001:2007
The Design, Software Development, Manufacture, Sales and Service of Marine Robotic Systems.
Hydroid, Inc
Single
Pocasset
MA
USA
ISO 9001:2008
The Design, Software Development, Manufacture, Sales and Service of Marine Robotic Systems.
HyperBranch Medical Technology, Inc
Single
Durham
NC
USA
EN ISO 13485:2012
Hyperion Inc.
Single
McLean
VA
USA
ISO 9001:2008
Secondary
Ensenada, Baja
California
Mexico
ISO 13485/CMDCAS
COMPANY
ICU Medical de Mexico S.A. de C.V.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
CNC Precision Machining Services and Mechanical Assemblies, Precision Machining of Metal and Plastic Parts, CNC Milling and Turning Machining.
Design, Manufacture, and Distribution of Sterile Disposable Microkeratome Blades, Retinal gases, Perfluorodecaline, Perfluorooctane, Implantable Silicone
Retinal Oil, Sterile and Non-Sterile Ophthalmic Instruments (Trocars, Iris Retractors,Scleral plugs, Trephines, and Cannulas).
The design, development and manufacture of crosslinked hydrogel polymer sealants and related delivery systems.
Management and Design of Information Technology Projects.
The design, manufacture, sterilization and distribution of intravenous catheters, IV administration sets, custom IV kits, IV connectors, molded subassemblies and accessories, enteral feeding valves, vial access devices,infusion sets and monitoring devices. The manufacture, repair and servicing of
optical modules for oxygen measurement. Irradiation sterilization of medical devices in accordance with ISO 11137-1:2006.
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
COMPANY
Profile
Type
CITY
STATE
Country
Scheme
Scope
Slovak Republic
EN ISO 13485:2012
The design, manufacture, sterilization and distribution of intravenous catheters, IV administration sets, custom IV kits, IV connectors, molded subassemblies and accessories, enteral feeding valves, vial access devices,infusion sets and monitoring devices. The manufacture, repair and servicing of
optical modules for oxygen measurement. Irradiation sterilization of medical devices in accordance with ISO 11137-1:2006.
ICU Medical Slovakia s.r.o.
Secondary
ICU Medical, Inc.
Secondary
Salt Lake City
UT
USA
ISO 13485/CMDCAS
The design, manufacture, sterilization and distribution of intravenous catheters, IV administration sets, custom IV kits, IV connectors, molded subassemblies and accessories, enteral feeding valves, vial access devices,infusion sets and monitoring devices. The manufacture, repair and servicing of
optical modules for oxygen measurement. Irradiation sterilization of medical devices in accordance with ISO 11137-1:2006.
ICU Medical, Inc.
Primary
San Clemente
CA
USA
ISO 13485/CMDCAS
The design, manufacture, sterilization and distribution of intravenous catheters, IV administration sets, custom IV kits, IV connectors, molded subassemblies and accessories, enteral feeding valves, vial access devices,infusion sets and monitoring devices. The manufacture, repair and servicing of
optical modules for oxygen measurement. Irradiation sterilization of medical devices in accordance with ISO 11137-1:2006.
IdentiGen Ltd
Single
Dublin 2
Ireland
ISO 9001:2008
The Provision of analytical testing services (Traceback TM and Administration)
IKE Micro
Single
Nashua
NH
USA
ISO 9001:2008
Contract Manufacture of Micro Electronics, RF/Microwave Components.
Immunetics, Inc
Single
Boston
MA
USA
ISO 13485/CMDCAS
The Design, Development, Manufacture and Distribution of ELISA Diagnostic Kits.
Immunotech S.A.S
Single
Marseille, Cedex 9
France
ISO 13485/CMDCAS
The Design, Development and Manufacture of In-Vitro Diagnostic Reagents, and In-Vitro Diagnostic Test Kits Used in the Diagnosis and/or Management
of Cancer, Endocrine Disorders, Fertility Testing, Immune Status, Autoimmune Diseases,and Bone Metabolism Disorders.9K Scope: The Design,
Development, Manufacture and Distribution of Research Products.
Immunotech s.r.o.
Single
Prague
Czech Republic
ISO 13485/CMDCAS
The Design, Manufacture and Distribution of In-Vitro Diagnostic Reagents, and In-Vitro Diagnostic Test Kits used in the Diagnosis and/or Management of
Cancer, Endocrine Disorders, Fertility Testing,Immune Status, Autoimmune Status, Autoimmune Disease, Prenatal Screening, Neonatal Screening,
Diabetes, and Bone Metabolism Disorders.CMDCAS Scope: The Design, Manufacture and Distribution of In-Vitro Diagnostic Reagents, and In-Vitro
Diagnostic Test Kits used in the Diagnosis and/or management of endocrine disorders, fertility testing and bone metabolism disorders.
INFICON Inc.
Single
East Syracuse
NY
USA
ISO 9001:2008
The design and manufacture of residual gas analyzers, gas chromatograph/mass spectrometers, thin film deposition monitors and controllers, and leak
detectors.
INFICON Inc.
Single
East Syracuse
NY
USA
ISO 14001:2004
The design and manufacture of residual gas analyzers, gas chromatograph/mass spectrometers, thin film deposition monitors and controllers, and leak
detectors.
Infinity Components
Single
Portsmouth
NH
USA
ISO 9001:2008
The distribution of IC's and semiconductors. The provision of inventory management and asset recovery programs.
Inmo-Tech Ltd.
Single
Co. Sligo
Ireland
EN ISO 13485:2012
Innerstep
Single
Scotts Valley
USA
I.S.EN ISO13485:2012
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
CA
MD Scope: Molding of medical device components, and assembly of components and subassemblies for the medical device industry.ISO9K Scope:
Contract Injection Moulding and Manufacturing.
ISO 13485: Integrated supply chain management, manufacture, and test of electronic and electromechanical systems and sub-systems for medical device
industry.ISO 9001: Integrated supply chain management, manufacture, and test of electronic and electromechanical systems and sub-systems for original
equipment manufactures.
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
Innovative Fabrication
Single
Lowell
MA
USA
ISO 9001:2008
InPress Technologies Inc.
Single
San Luis Obispo
CA
USA
ISO 13485/CMDCAS
INTA Technologies
Single
Santa Clara
CA
USA
AS 9100 - C
InTECHrity Inc
Single
Irvine
CA
USA
EN ISO 13485:2012
Secondary
Shenzhen
China
IECQ ITL
Environmental and reliability testing for passive, active and electromechanical components, (IEC60068, IEC 60529, IPC-A-610, MIL-STD 202, MIL-STD810, MIL-STD-883, JESD-22 series, ANSI/ESD STM 5.1, 5.2, 5.3.1, ISTA 2A, BELL Core GR-63, J-STD-020),including Free fall test, High temperaure
test, Humidity storage test, Low pressure, Altitude test, Low temperature test, Mechanical shock test, Mixed flowing gas test, Salt spray test, Solar
radiation test, Temperature cycling test, Thermal shocktest, Vibration test, High Temperature Operating Life test and Dye penetration test.
IECQ ITL
The failure analysis test of PCBA and electromechanical components (by standards of IPC-TM-650 2.1.1, IPC-A-600, IPC-A-610, IPC-6012, J-STD-035, JSTD-020, JESD22A121, JESD201, and MIL-STD-883), including Cross section test,Scanning accoustic microscope test, X-ray/ Radiography test,
Scanning electron microscope test, Visual inspection test, Focused ion beam test, Emission microscope test, Probe test, Electrostatic discharge test
(HBM/MM), andLatch-up test.
IECQ ITL
Environmental and reliability testing, inspection and failure analysis (by standards of IEC 60068, MIL-STD-202, MIL-STD-810, MIL-STD-883, JESD-22
series, ANSI/ESD STM5.1/5.2/5.3, BELL Core GR-63, J-STD-020, AEC-Q100, AEC-Q101, IPC-TM-650, IPC-A-600, IPC-A-610, IPC-6012, J-STD-035,
JESD201, EIAJ ED-4701),Including tests of:Electrostatic discharge test (HBM/MM/CDM), External visual, Emission microscope, Focused Ion Beam,
Highly Accelerated Temperature and Humidity Stress test, High Temperature Storage Life, Humidity storage, Latch-up, Low Temperature Storage Life,
Micro section, Moisture Reflow Sensitivity Classification for Nonhermetic Solid State Surface Mount Devices, Preconditioning of Nonhermetic Surface
Mount Device Prior To Reliability, Probe station, Accelerated Moisture Resistance Unbiased Autoclave(Pressure cook), Scanning electron microscope,
Temperature and Humidity Bias Life, Temperature Bias and Operating Life, Temperature cycling, Thermal shock, Cycled Temperature Humidity Bias Life,
Accelerated Moisture Resistance -Unbiased HAST
COMPANY
Integrated Service Technology
Integrated Service Technology
Integrated Service Technology Inc
Primary
Secondary
Shenzhen
Shanghai City
China
China
Scope
Dicing and machining of any hard and brittle material for diverse applications including the medical, microelectronics and optical industries.
The Design, Manufacture and Distribution of non-active Women’s Health Care Products for the Treatment of Post-Partum Hemmorage
Manufacture of electroplated and metallized ceramic and metal parts and assemblies.
Contract manufacturing of non-sterile therapeutic medical devices used in the treatment of speech and swallowing disorders.
Integrated Service Technology Inc.
Secondary
Jiangsu
China
IECQ ITL
Environmental and reliability testing, inspection and failure analysis (by standards of IEC 60068 / 60529; ISO 105 / 7253 / 7384 / 9022 / 9227 / 10060 /
11341 /12097 / 14892 /16750 / 20653; IPC-A-600 / 610 / 6012; IPC-TM-650; ISTA; EIAJ ET-7401/7402; EIA-364; MIL-STD-202 / 810 / 883; ASTM B117 /
D1735 / D2247 / D3002 / D5894 / G85/ G155; JESD-22 series; JESD 201; J-STD-002 / 003 / 004 / 020 / 035; JIS Z 3197 / 3198; JIS D 0203; DIN 75220 /
40050-9; GB 2423 /8410 / 10485; GB/T 9491 / 19949 ; DELL sepc; VW 80101; GMW 3172; MGRES:62.21.001; BMW GS 95003; BMW GS 95011; PSA
B2117130; Nissan 24012NDS04; FMVSS 571.302, SAE J1885/J2412/J1960/J2527, AATCC 16-3/169-1, TL-226, DIN EN ISO 1518 / 2409), Including tests
of: Compression; Dye penetration; External visual; Flammability; Free fall; Highly accelerated temperature and humidity stress; Highly Accelerated Life;
High temperature; Humidity; Low air pressure (altitude); Low temperature; Micro section; Flowing mixed gas corrosion; Moisture sensitivity levels; Pressure
cook; Shear and Pull; Radiography(X-ray); Salt spray; Degrees of protection (dust and rain); Scanning acoustic microscope; Scanning electron
microscope; Shock; Solar radiation; Insulation resistance; Electrochemical migration; Conductive anodic filament; Thermal shock; Vibration; Wetting
balance/Solderability; Temperature/humidity cyclic; Mould growth; Dew test; Chemical resistance; and Xenon arc lamp test; Abrasion behaviour; Crosscut;
and Scratch resistance.
Integrated Service Technology Inc.
Secondary
Hsin-Chu City 300
Taiwan, R.O.C.
IECQ ITL
Environmental and reliability testing (International Standard & MIL-STD-810, etc), including Low temperature test, High temperature test, Humidity storage
test,Temperature cycling test, Thermal shock test, Pressure cook test, and Highly accelerated temperature and humidity stress test.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
COMPANY
Integrated Service Technology, Inc.
Profile
Type
CITY
STATE
Country
Scheme
Scope
1. Environmental and reliability testing (JEDEC, AEC-Q100/Q101/Q200 , IEC 60529, IEC 60068-2 -1 to IEC 60068-2 -64, Mil-STD-810 & Mil-STD-883)
Electrostatic discharge test, Low temperature, High temperature test, Humidity storage test, Temperature cycling test, Thermal shock test, Pressure cook
test, Highly Accelerated Temperature and Humidity Stress test (JESD22 A110), Low pressure, altitude test, Temperature and Humidity Bias Life test,
Temperature, Bias and Operating Life test (JESD22 A108), Rain test, Salt spray test, Mixed flowing gas test, Solar radiation test, Sand and dust test,
Preconditioning of Nonhermetic Surface Mount Device Prior To Reliability Testing, Surface Insulation Resistance and Electrochemical Migration,
Solderability (wetting Balance) test, Vibration test, Shock test, Free fall test, Acoustic noise test and LED Luminaries test, IC EMC test, Gate Leakage test,
Endurance & Data Retention test and Power & Temperature cycling test and Early Life Failure Rate Test (AEC Q100-008).
2. Failure analysis and material analysis of semiconductor integrated circuits, electronic components and PCB/PCBA, including FIB (Focused Ion Beam),
Electrical Analysis, Sample Preparation (Decap, X-section, etc), NDE (Non-destructive Engineering), Physical & Chemical Analysis (Including Hazardous
Substances) and IC package.
3. 2nd Level Integration Platform Service, including SMT and 2nd reliability Services (Temperature Cycle (IPC9701) Test, Board Level Drop Test, Shock
Test, Vibration Test, Bending Test (Cyclic bend & Monotonic bend (IPC9702)), Pull/Push Test and SMT and PCBA test (Cold ball pull test, wire pull test,
ball shear test and hot bond pull test)).
Single
Pine Lake
GA
Taiwan, R.O.C.
IECQ ITL
Intel Corporation
Primary
Santa Clara
CA
USA
OHSAS 18001:2007
The Manufacture of Semiconductors.
Intel Corporation
Secondary
Chandler
AZ
USA
OHSAS 18001:2007
The manufacturing of semi-conductors.
Intel Corporation
Secondary
Hudson
MA
USA
OHSAS 18001:2007
The manufacturing of semiconductors.
Intel Corporation
Secondary
Rio Rancho
NM
USA
OHSAS 18001:2007
The manufacturing of semiconductors
Intel Corporation
Secondary
Hillsboro
OR
USA
OHSAS 18001:2007
The manufacturing of semiconductors
Intel Corporation
Secondary
Dalian, LN
China
ISO 9001:2008
Wafer Fabrication, Associated Equipment and Processes.
Intel Corporation
Secondary
Santa Clara
CA
USA
ISO 9001:2008
Wafer Fabrication, Associated Equipment and Processes.
Intel Corporation
Secondary
Chandler
AZ
USA
ISO 14001:2004
The manufacturing of semi-conductors.
Intel Corporation
Single
Chandler
AZ
USA
ISO 9001:2008
Distribution of microprocessors.
Intel Corporation
Primary
Chandler
AZ
USA
ISO 9001:2008
Design, Develop, Assemble and Test Semiconductor Components, Associated Equipment and Processes.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
Intel Corporation
Secondary
Hillsboro
OR
USA
ISO 14001:2004
The manufacturing of semiconductors.
Intel Corporation
Secondary
Hudson
MA
USA
ISO 14001:2004
The manufacturing of semiconductors.
Intel Corporation
Secondary
Rio Rancho
NM
USA
ISO 14001:2004
The manufacturing of semiconductors
Intel Corporation
Secondary
Aloha
OR
USA
ISO 14001:2004
The manufacturing of semiconductors
Intel Corporation
Secondary
Chandler
AZ
USA
ISO 14001:2004
The manufacturing of semiconductors
Intel Corporation
Primary
Santa Clara
CA
USA
ISO 14001:2004
The manufacturing of semi-conductors.
Intel Corporation
Secondary
Rio Rancho
NM
USA
ISO 9001:2008
Wafer Fabrication, Associated Equipment and Processes.
Intel Corporation
Secondary
Aloha
OR
USA
ISO 9001:2008
Wafer Fabrication, Associated Equipment and Processes.
Intel Corporation
Secondary
Aloha
OR
USA
OHSAS 18001:2007
The manufacturing of semiconductors
Intel Corporation
Secondary
Chandler
AZ
USA
OHSAS 18001:2007
The manufacturing of semiconductors
Intel Corporation - ATTD
Secondary
Chandler
AZ
USA
ISO 9001:2008
Assemble and Test Semiconductor Components, Associated Equipment and Processes.
Intel Corporation - D1C
Secondary
Hillsboro
OR
USA
ISO 9001:2008
Wafer Fabrication, Associated Equipment and Processes.
Intel Corporation - Fab 17
Secondary
Hudson
MA
USA
ISO 9001:2008
Wafer Fabrication, Associated Equipment and Processes.
COMPANY
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Scope
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
Intel Corporation - Fab 24
Secondary
Intel Corporation - Fab 28 and IDPj
COMPANY
Country
Scheme
Leixlip, County Kildare
Ireland
ISO 9001:2008
Wafer Fabrication, Associated Equipment and Processes.
Secondary
Qiryat Gat
Israel
ISO 9001:2008
Wafer Fabrication, Associated Equipment and Processes
Intel Corporation - Fab 32
Secondary
Chandler
USA
ISO 9001:2008
Wafer Fabrication, Associated Equipment and Processes.
Intel Corporation - KMCO
Secondary
Kulim, Kedah
Malaysia
ISO 9001:2008
Assemble and Test Semiconductor Components, Associated Equipment and Processes.
Intel Corporation - KMO
Secondary
Kulim
Kedah
Malaysia
ISO 9001:2008
Assemble and Test Semiconductor Components, Associated Equipment and Processes.
Intel Corporation ATTD
Secondary
Hillsboro
OR
USA
ISO 9001:2008
Assemble and Test Semiconductor Components, Associated Equipment and Processes
Primary
Chandler
AZ
USA
ISO 9001:2008
Wafer Fabrication, Associated Equipment and Processes.
Intel Corporation-GPEO-M
Secondary
Kedah Darul Aman
Malaysia
ISO 9001:2008
Assemble and Test Semiconductor Components, Associated Equipment and Processes.
Intel Corporation-PG AT
Secondary
Penang
Malaysia
ISO 9001:2008
Assemble and Test Semiconductor Components, Associated Equipment and Processes.
Single
Amsterdam
The Netherlands
ISO 9001:2008
The distribution and storage of all Finished Goods for the Europe, Middle East and Africa (EMEA) region.
Intel Ireland Ltd.
Secondary
Leixlip, County Kildare
Ireland
OHSAS 18001:2007
The manufacturing of semiconductors.
Intel Ireland Ltd.
Secondary Leixlip, County Kildare
Ireland
ISO 14001:2004
The manufacturing of semiconductors
Intel Israel
Secondary
Israel
ISO 14001:2004
The manufacturing of semiconductors
Intel Corporation-Fab/Sort Manufacturing
Intel International BV
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Qiryat Gat
STATE
AZ
Scope
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
Intel Israel
Secondary
Intel Israel International Die
COMPANY
Country
Scheme
Qiryat Gat
Israel
OHSAS 18001:2007
Secondary
Jerusalem
Israel
ISO 14001:2004
Intel Israel International Die
Secondary
Jerusalem
Israel
OHSAS 18001:2007
Intel Israel International Die
Secondary
Jerusalem
Israel
ISO 9001:2008
Wafer Fabrication, Associated Equipment and Processes
Intel Products (Chengdu) Ltd
Secondary
Chengdu, Sichuan
China
ISO 14001:2004
The manufacture of semiconductors
Intel Products (Chengdu) Ltd
Secondary
Chengdu, Sichuan
China
OHSAS 18001:2007
Intel Products (Chengdu) Ltd
Single
Chengdu
China
ISO 50001
Intel Products (Chengdu) Ltd - CDMO
Secondary
Chengdu, Sichuan
China
ISO 9001:2008
Assemble and Test Semiconductor Components, Associated Equipment and Processes.
Intel Products (Chengdu) Ltd. - CDCO
Secondary
Chengdu, Sichuan
China
ISO 9001:2008
Assemble and Test Semiconductor Components, Associated Equipment and Processes.
Intel Products (M) Sdn. Bhd.
Secondary
Kulim
Kedah
Malaysia
OHSAS 18001:2007
The manufacturing of semiconductors
Intel Products (M) Sdn. Bhd.
Secondary
Kulim
Kedah
Malaysia
ISO 14001:2004
The manufacturing of semiconductors
Intel Products Vietnam
Secondary
Ho Chi Minh City
Vietnam
ISO 9001:2008
Site Specific Scope: Assemble and Test Semiconductor Components, Associated Equipment and Processes.Main Cert Scope: Design, Develop,
Assemble and Test Semiconductor Components, Associated Equipment and Processes.
Intel Products Vietnam
Single
Ho Chi Minh City
Vietnam
ISO 50001
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
STATE
Scope
The manufacturing of semiconductors
The manufacturing of semi-conductors.
The Manufacture of Semiconductors.
The manufacturing of semiconductors
Manufacture assembly and test of semiconductors.
Assembly and Test of Semiconductor Components, associated equipment and processes.
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
Intel Products Vietnam, Ltd.
Secondary
Intel Products Vietnam, Ltd.
COMPANY
Country
Scheme
Ho Chi Minh City
Vietnam
ISO 14001:2004
The manufacturing of semiconductors
Secondary
Ho Chi Minh City
Vietnam
OHSAS 18001:2007
The manufacturing of semiconductors
Intel Semiconductor (Dalian) Ltd.
Secondary
Dalian, LN
China
ISO 14001:2004
Manufacturing of semiconductors.
Intel Semiconductor (Dalian) Ltd.
Secondary
Dalian, LN
China
OHSAS 18001:2007
Manufacturing of semiconductors.
Intel Technology Sdn. Bhd.
Secondary
Penang
Malaysia
OHSAS 18001:2007
The manufacture of semi-conductors.
Intel Technology Sdn. Bhd.
Secondary
Penang
Malaysia
ISO 14001:2004
The manufacture of semi-conductors.
Intel-GE Care Innovations, LLC
Secondary
Roseville
CA
USA
ISO 13485/CMDCAS
The Design, Development, Manufacturing and Distribution, and Service of Health Information Systems to Aggregate and Transmit Data for Patient Care
Management
Intel-GE Care Innovations, LLC
Primary
Roseville
CA
USA
ISO 13485/CMDCAS
The Design, Development, Manufacturing and Distribution, and Service of Health Information Systems to Aggregate and Transmit Data for Patient Care
Management
International Titanium Corporation
Single
New Brighton
PA
USA
ISO 9001:2008
Provision of grinding (defect removal, surface preparation and sizing) of metals (e.g. titanium, stainless steel, carbon steel, aluminium, copper, etc.) in
customer supplied form (e.g. ingot, billet, bloom, slab, etc.)
Interroll Engineering West Inc.
Single
Canon City
CO
USA
ISO 9001:2008
The design and manufacture of conveyors and conveying equipment.
Intersect ENT
Single
Menlo Park
CA
USA
ISO 13485/CMDCAS
Interstate Manufacturing Associates, Inc
Single
Newport
NH
USA
ISO 9001:2008
Interventional Spine, Inc.
Single
Irvine
CA
USA
EN ISO 13485:2003
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
STATE
Scope
The Design and Development, Manufacturing and Distribution of Sinus Stents and Drug Coated Sinus Stents.
Manufacture and sales of machined parts and assemblies for commercial and industrial use.
The design, manufacture and distribution of orthopedic bone fixation devices and associated non-sterile manual surgical instruments.
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
Single
Huntsville
AL
USA
ISO 9001:2008
iRhythm Technologies, Inc.
Secondary
Lincolnshire
IL
USA
ISO 13485/CMDCAS
The design, manufacture and distribution of wearable, single-patient-use Electrocardiograph (ECG) monitors, and associated analysis software. The
Provision of ECG data recovery, analysis, and report generation services for physicians.
iRhythm Technologies, Inc.
Secondary
Huntington Beach
CA
USA
ISO 13485/CMDCAS
The design, manufacture and distribution of wearable, single-patient-use Electrocardiograph (ECG) monitors, and associated analysis software. The
Provision of ECG data recovery, analysis, and report generation services for physicians.
iRhythm Technologies, Inc.
Primary
San Francisco
CA
USA
ISO 13485/CMDCAS
The design, manufacture and distribution of wearable, single-patient-use Electrocardiograph (ECG) monitors, and associated analysis software. The
Provision of ECG data recovery, analysis, and report generation services for physicians.
Irvine Scientific
Primary
Santa Ana
CA
USA
ISO 13485/CMDCAS
The Design, Development, Manufacture, Contract Manufacture and Distribution of Medical Devices Consisting of Tissue Culture Products and In-Vitro
Diagnostics for use with IVF, and Assisted Reproductive Products for In-Vitro Fertilization use.
Irvine Scientific
Secondary
Santa Ana
CA
USA
ISO 13485/CMDCAS
The Design, Development, Manufacture, Contract Manufacture and Distribution of Medical Devices Consisting of Tissue Culture Products and In-Vitro
Diagnostics for use with IVF, and Assisted Reproductive Products for In-Vitro Fertilization use.
Irvine Scientific
Secondary
Santa Ana
CA
USA
ISO 13485/CMDCAS
The Design, Development, Manufacture, Contract Manufacture and Distribution of Medical Devices Consisting of Tissue Culture Products and In-Vitro
Diagnostics for use with IVF, and Assisted Reproductive Products for In-Vitro Fertilization use.
Irvine Scientific - Ireland
Single
Co. Wicklow
Ireland
EN ISO 13485:2012
The sales, storage and distribution of medical devices consisting of tissue culture products. In vitro diagnostics such as amniostat for foetal lung maturity,
and assisted reproduction products for use in In vitro fertilization use.
I-TEK Medical Technologies
Single
St. Paul
MN
USA
EN ISO 13485:2012
Contract design and manufacturing services for sterile and non-sterile medical devices and medical device assemblies.
Ivantis, Inc.
Single
Irvine
CA
USA
ISO 13485/CMDCAS
The Design, Manufacture and Distribution of Sterile Implantable Ophthalmic Devices for Treatment of Glaucoma.
JACER Corporation
Single
Fairfax
VA
USA
ISO 9001:2008
JACER Corporation Provides the Federal Government with Support Services that include: Program and Project Management, Financial and Business
Support Management,Logistics and Resource Management, Administrative Support Services, Strategic Consulting, and Total Information
Management/Information Technology Solutions.
JL Precision
Single
San Jose
CA
USA
ISO 9001:2008
Precision Sheet Metal, CNC Machining and Custom Framing
Jones Lang LaSalle
Single
Royal Oak
MI
USA
ISO 9001:2008
Delivery of Facility Management Services at Client Facilities.
COMPANY
Intuitive Research & Technology Corp.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Scope
Technical and engineering services, and the provision of management and technical services, programmatic support, system engineering, quality
management, engineering and production systems support, and technology management solutions tothe Department of Defense, government agencies
and commercial customers.
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
Jus-Com Telecommunications, Inc.
Single
Indianapolis
IN
USA
TL 9000 R5.0/5.0
TL9000-V Scope: Network Element Integration Service for the following category 7.1.1 - InstallationISO9K Scope: Network Element Integration Service
KAPP Surgical Instrument, Inc.
Single
Warrensville Heights
OH
USA
EN ISO 13485:2003
Design, Manufacture, Service and Distribution of Reusable Instruments and Surgical Accessories used for Cardiovascular and Orthopaedic,Implantable
Gastric Radiographic Marker, Small Joint Orthopaedic Prostheses Implant, and Sterile Surgical Securement Device.
Katalyst Surgical, LLC
Single
Chesterfield
MO
USA
ISO 13485/CMDCAS
The Design, Manufacture, and Distribution of Sterile and Non-Sterile Instruments and Accessories for Opthalmic, Neurosurgery, and General Surgery.
Kimball Electronics Group - Jasper
Secondary
Jasper
IN
USA
AS 9100 - C
Kimball Electronics Group - Jasper
Primary
Jasper
IN
USA
EN ISO 13485:2003
Kimball Electronics Group - Jasper
Primary
Jasper
IN
USA
AS 9100 - C
Kimball Electronics Group - Jasper
Secondary
Jasper
IN
USA
EN ISO 13485:2003
Primary
Jasper
IN
USA
ISO 9001:2008
The design, manufacture and sales of office furniture products and sub-assemblies.
Kimball Office - Jasper
Secondary
Jasper
IN
USA
ISO 9001:2008
The design, manufacture and sales of office furniture products and sub-assemblies.
Kimball Office - Jasper
Secondary
Jasper
IN
USA
ISO 9001:2008
The design, manufacture and sales of office furniture products and sub-assemblies.
Kimball Office - Salem
Secondary
Salem
IN
USA
ISO 9001:2008
The design, manufacture and sales of office furniture products and sub-assemblies.
Kimball Office Products - Post Falls
Secondary
Post Falls
ID
USA
ISO 9001:2008
The design, manufacture and sales of office furniture products and sub-assemblies.
Single
Paris
France
TL 9000 R5.0/5.0
COMPANY
Kimball Office - CMG
Laboratoire Européen ADSL (LEA)
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Scope
The provision of electronics manufacturing services including Test Development and Support, New Product Introduction, SMT, Thru-hole (including RoHS),
Conformal Coating, and Printed Circuit Board Assembly (PCBA) for the Aviation, Space and DefenseIndustries.
MD Scope: The Provision of Electronic Manufacturing and Assembly Services for the Medical Industry, Including the Subcontract Manufacture of Cranial
Electrotherapy Stimulator Devices.ISO9K Scope: An electronics manufacture service provider for contract manufacturing services for the computer,
industrial, medical, public safety, telecommunications and transportation industries.
The provision of electronics manufacturing services including Test Development and Support, New Product Introduction, SMT, Thru-hole (including RoHS),
Conformal Coating, and Printed Circuit Board Assembly (PCBA) for the Aviation, Space and DefenseIndustries.
MD Scope: The Provision of Electronic Manufacturing and Assembly Services for the Medical Industry, Including the Subcontract Manufacture of Cranial
Electrotherapy Stimulator Devices.ISO9K Scope: An electronics manufacture service provider for contract manufacturing services for the computer,
industrial, medical, public safety, telecommunications and transportation industries.
TL9000-H Scope: DESIGN, MANUFACTURING, TESTING AND SALES OF ELECTRONIC CARDS FOR BROADBAND COMMUNICATION ( XDSL
Technologies); Product Category: 6.2.3.1 Data Modems
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
COMPANY
Lake Region Medical
Lake Region Medical
Profile
Type
CITY
STATE
Country
Scheme
Primary
Chaska
MN
USA
ISO 13485/CMDCAS
MD: The design, development, manufacture and distribution of sterile and non-sterile guidewires used in peripheral and cardiac applications, torque
devices, stylets, biopsy instruments, custom metal coils and machined medical components. Contractmanufacturing of stents and stent delivery
systems.CMDCAS: The design, development, manufacture and distribution of sterile and non-sterile guidewires for the areas of gastroenterology/urology
and vascular guidewires for peripheral and cardiac use.
ISO 13485/CMDCAS
MD: The design, development, manufacture and distribution of sterile and non-sterile guidewires used in peripheral and cardiac applications, torque
devices, stylets, biopsy instruments, custom metal coils and machined medical components. Contractmanufacturing of stents and stent delivery
systems.CMDCAS: The design, development, manufacture and distribution of sterile and non-sterile guidewires for the areas of gastroenterology/urology
and vascular guidewires for peripheral and cardiac use.
Secondary
Chaska
MN
USA
Scope
Lake Region Medical
Secondary
Chaska
MN
USA
ISO 13485/CMDCAS
MD: The design, development, manufacture and distribution of sterile and non-sterile guidewires used in peripheral and cardiac applications, torque
devices, stylets, biopsy instruments, custom metal coils and machined medical components. Contractmanufacturing of stents and stent delivery
systems.CMDCAS: The design, development, manufacture and distribution of sterile and non-sterile guidewires for the areas of gastroenterology/urology
and vascular guidewires for peripheral and cardiac use.
Lake Region Medical
Secondary
Chaska
MN
USA
ISO 13485/CMDCAS
MD: The design, development, manufacture and distribution of sterile and non-sterile guidewires used in peripheral and cardiac applications, torque
devices, stylets, biopsy instruments, custom metal coils and machined medical components. Contractmanufacturing of stents and stent delivery
systems.CMDCAS: The design, development, manufacture and distribution of sterile and non-sterile guidewires for the areas of gastroenterology/urology
and vascular guidewires for peripheral and cardiac use.
Lake Region Medical
Secondary
Chaska
MN
USA
ISO 13485/CMDCAS
MD: The design, development, manufacture and distribution of sterile and non-sterile guidewires used in peripheral and cardiac applications, torque
devices, stylets, biopsy instruments, custom metal coils and machined medical components. Contractmanufacturing of stents and stent delivery
systems.CMDCAS: The design, development, manufacture and distribution of sterile and non-sterile guidewires for the areas of gastroenterology/urology
and vascular guidewires for peripheral and cardiac use.
Lake Region Medical Ltd
Single
Co Wexford
Ireland
OHSAS 18001:2007
The design & development, manufacture and distribution of sterile and non-sterile guidewires used in peripheral and cardiac applications
Lake Region Medical Ltd
Single
Co. Wexford
Ireland
ISO 14001:2004
The design & development, manufacture and distribution of sterile and non-sterile guidewires used in peripheral and cardiac applications
Lake Region Medical Ltd.
Single
New Ross
Co. Wexford
Ireland
ISO 13485/CMDCAS
Lam Research Corporation
Secondary
Livermore
CA
USA
ISO 9001:2008
The Design, Manufacture, Installation and Servicing of Semiconductor Wafer Fab Equipment.
Lam Research Corporation
Secondary
Livermore
CA
USA
ISO 14001:2004
The Design, Manufacture, Installation and Servicing of Semiconductor Wafer Fab Equipment.
Lam Research Corporation
Primary
Fremont
CA
USA
ISO 9001:2008
The Design, Manufacture, Installation and Servicing of Semiconductor Wafer Fab Equipment.
Lam Research Corporation
Primary
Fremont
CA
USA
ISO 14001:2004
The Design, Manufacture, Installation and Servicing of Semiconductor Wafer Fab Equipment.
Lam Research Corporation
Single
Fremont
CA
USA
OHSAS 18001:2007
The Design, Manufacture, Installation and Servicing of Semiconductor Wafer Fab Equipment.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
The Design & Development, Manufacture and Distribution of Sterile and Non-Sterile Guidewires Used in Peripheral and Cardiac Applications.
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
Lamar Tool & Die Casting, Inc.
Single
Modesto
CA
USA
ISO 9001:2008
The production and distribution of aluminum, brass and zinc die cast products.
Lamb Depollution
Single
Hooks
TX
USA
ISO 14001:2004
The collection and disposition of automotive liquids and fuels.
Lampin Corporation
Single
Uxbridge
MA
USA
ISO 9001:2008
Manufacture of Precision Mechanical Components and Assemblies.
Primary
Montebello
CA
USA
ISO 9001:2008
The Purchase and Sale of Products and Services including Custom and Stock Packaging Products and related Machinery, Janitorial Supplies, Design
Services and Turn Key Assembly.
Landsberg - Atlanta
Secondary
Atlanta
GA
USA
ISO 9001:2008
The Purchase and Sale of Products and Services Including Custom and Stock Packaging Products and Related Machinery and Janitorial Supplies and
Turn Key Assembly.
Landsberg Dallas
Secondary
Grapevine
TX
USA
ISO 9001:2008
The Purchase and Sale of Products and Services Including Custom and Stock Packaging Products and Related Machinery and Janitorial Supplies.
Landsberg Denver
Secondary
Aurora
CO
USA
ISO 9001:2008
The Purchase and Sale of Products and Services Including Custom and Stock Packaging Products and Related Machinery and Janitorial Supplies.
Landsberg EPS Southwest
Secondary
Montebello
CA
USA
ISO 9001:2008
The Purchase and Sale of Products and Services Including Custom and Stock Packaging Products and Related Machinery, Janitorial Supplies and Design
Services.
Landsberg Fresno
Secondary
Fresno
CA
USA
ISO 9001:2008
The Purchase and Sale of Products and Services Including Custom and Stock Packaging Products and Related Machinery and Janitorial Supplies.
Landsberg Guadalajara
Secondary
Zapopan, Jalisco
Mexico
ISO 9001:2008
The Purchase and Sale of Products and Services including Custom and Stock Packaging Products and related Machinery and Janitorial Supplies.
Landsberg Houston
Secondary
Houston
TX
USA
ISO 9001:2008
The Purchase and Sale of Products and Services Including Custom and Stock Packaging Products and Related Machinery,and Janitorial Supplies.
Landsberg Indianapolis
Secondary
Indianapolis
IN
USA
ISO 9001:2008
The Purchase and Sale of Products and Services Including Custom and Stock Packaging Products and Related Machinery, Janitorial Supplies, and
Design Services.
Landsberg Juarez
Secondary
Chihuahua
Mexico
ISO 9001:2008
The Purchase and Sale of Products and Services Including Custom and Stock Packaging Products and Related Machinery, Janitorial Supplies and Design
Services.
COMPANY
Landsberg
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Scope
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
Landsberg Memphis
Secondary
Memphis
TN
USA
ISO 9001:2008
The Purchase and Sale of Products and Services Including Custom and Stock Packaging Products and Related Machinery and Janitorial Supplies.
Landsberg Mexicali
Secondary
Mexicali
Baja
California
Mexico
ISO 9001:2008
The Purchase and Sale of Products and Services Including Custom and Stock Packaging Products and Related Machinery, Janitorial Supplies and Turn
Key Assembly.
Landsberg New Jersey
Secondary
Cranbury
NJ
USA
ISO 9001:2008
The Purchase and Sale of Products and Services Including Custom and Stock Packaging Products and Related Machinery and Janitorial Supplies.
Landsberg Ontario (CA)
Secondary
Fontana
CA
USA
ISO 9001:2008
The Purchase and Sale of Products and Services Including Custom and Stock Packaging Products and Related Machinery, Janitorial Supplies and Design
Services.
Landsberg Orange County
Secondary
Buena Park
CA
USA
ISO 9001:2008
The Purchase and Sale of Products and Services Including Custom and Stock Packaging Products and Related Machinery, Janitorial Supplies and Design
Services.
Landsberg Orora Chicago
Secondary
Lombard
IL
USA
ISO 9001:2008
The Purchase and Sale of Products and Services Including Custom and Stock Packaging Products and Related Machinery, Janitorial Supplies and Design
Services.
Landsberg Phoenix
Secondary
Phoenix
AZ
USA
ISO 9001:2008
The Purchase and Sale of Products and Services Including Custom and Stock Packaging Products and Related Machinery and Janitorial Supplies.
Landsberg Portland
Secondary
Wilsonville
OR
USA
ISO 9001:2008
The Purchase and Sale of Products and Services Including Custom and Stock Packaging Products and Related Machinery, Janitorial Supplies, Design
Services and Turn Key Assembly.
Landsberg Sacremento
Secondary
Rocklin
CA
USA
ISO 9001:2008
The Purchase and Sale of Products and Services Including Custom and Stock Packaging Products and Related Machinery, Janitorial Supplies, Design
Services and Turn Key Assembly.
Landsberg San Diego
Secondary
San Marcos
CA
USA
ISO 9001:2008
The Purchase and Sale of Products and Services Including Custom and Stock Packaging Products and Related Machinery, Janitorial Supplies, Design
Services and Turn Key Assembly.
Landsberg San Jose
Secondary
Newark
CA
USA
ISO 9001:2008
The Purchase and Sale of Products and Services including Custom and Stock Packaging Products and Related Machinery, Janitorial Supplies, and
Design Services.
Landsberg Santa Barbara
Secondary
Oxnard
CA
USA
ISO 9001:2008
The Purchase and Sale of Products and Services Including Custom and Stock Packaging Products and Related Machinery, Janitorial Supplies and
Design.
Landsberg Seattle
Secondary
Kent
WA
USA
ISO 9001:2008
The Purchase and Sale of Products and Services Including Custom and Stock Packaging Products and Related Machinery and Janitorial Supplies.
COMPANY
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Scope
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
Landsberg St. Louis
Secondary
Earth City
MO
USA
ISO 9001:2008
The Purchase and Sale of Products and Services Including Custom and Stock Packaging Products and Related Machinery and Janitorial Supplies.
Landsberg Tijuana
Secondary
Tijuana, BC
Mexico
ISO 9001:2008
The Purchase and Sale of Products and Services Including Custom and Stock Packaging Products and Related Machinery, Janitorial Supplies and Design
Services.
Lastar, Inc.
Secondary
Dayton
OH
USA
ISO 9001:2008
The design, manufacture, and distribution of fiber optic, copper, and audio/video cable assemblies for the telecommunications and data networking
industries.
Lastar, Inc.
Primary
Moraine
OH
USA
ISO 9001:2008
The design, manufacture, and distribution of fiber optic, copper, and audio/video cable assemblies for the telecommunications and data networking
industries
Lastar, Inc.
Secondary
Albia
IA
USA
ISO 9001:2008
The design, manufacture, and distribution of fiber optic, copper, and audio/video cable assemblies for the telecommunications and data networking
industries
Lastar, Inc.
Secondary
Hickory
NC
USA
ISO 9001:2008
The design, manufacture, and distribution of fiber optic, copper, and audio/video cable assemblies for the telecommunications and data networking
industries
Latva Machine, Inc.
Single
Newport
NH
USA
ISO 9001:2008
Precision machining and turning facility specializing in complex components and assemblies from exotic material in bar stock, plate, casting and forging
material for the Aerospace, Military and Commercial applications.
Le Belge Chocolatier
Single
Napa
CA
USA
ISO 9001:2008
The Manufacture of Customized European Style Chocolates.
LFI Inc.
Secondary
Walpole
MA
USA
I.S.EN ISO13485:2012
The Contract manufacturing and machining of medical device components, and contract assembly and packaging of medical devices.
LFI Inc.
Primary
Smithfield
RI
USA
EN ISO 13485:2012
The Contract manufacturing and machining of medical device components, and contract assembly and packaging of medical devices.
Life Instrument Corporation
Single
Braintree
MA
USA
EN ISO 13485:2012
The design, manufacture, service and distribution of reusable hand-held surgical instrumentation.
Life Science Outsourcing, Inc.
Single
Brea
CA
USA
ISO 13485:2003
LightIntegra Technology Inc.
Single
Vancouver BC
Canada
EN ISO 13485:2012
COMPANY
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Scope
The contract Design, Manufacturing, package testing, warehousing, distribution, cleaning and decontamination of non-active invasive and non-invasive
surgical devices, diagnostic equipment and active electro-medical device including surgical andmonitoring probes, contract moist heat sterilization services
in accordance with ISO 17665-1:2006 and contract ethylene oxide sterilization services in accordance with ISO 11135:2007.
Design and development of active platelet quality testing systems and non-active sterile and non-sterile sampling sets.
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
Linear & Metric Co
Single
Londonderry
NH
USA
ISO 9001:2008
Sales and Production of Machined Products.
Logan Instruments Inc.
Single
Everett
MA
USA
ISO 9001:2008
Manufacture and Repair of Hand-Held Surgical Instruments for Various Surgical Applications.
LTX-Credence Corporation
Secondary
Milpitas
CA
USA
ISO 9001:2008
The design, development, manufacture, installation and service support of linear, digital, mixed signal and discrete semiconductor test equipment and
associated applications in the North America, Europe and Asia.
LTX-Credence Corporation
Primary
Norwood
MA
USA
ISO 9001:2008
The design, development, manufacture, installation and service support of linear, digital, mixed signal and discrete semiconductor test equipment and
associated applications in North America, Europe and Asia.
Lumen Dynamics
Single
Ontario
Canada
ISO 9001:2008
Design, manufacture and service of precision light sources and delivery systems for use in photochemical and illumination applications.
Lumen Dynamics
Single
Ontario
Canada
ISO 14001:2004
Design, manufacture and service of precision light sources and delivery systems for use in photochemical and illumination applications.
Lumigen, Inc.
Single
Southfield
MI
USA
ISO 9001:2008
Design, Development and Manufacture of Chemiluminescent Reagents.
Lumitex Medical Devices, Inc.
Secondary
Strongsville
OH
USA
ISO 13485/CMDCAS
Design and Development, Production, Contract Manufacturing and Distribution of Sterile and Non-sterile Medical Illumination Devices and Non-sterile
Phototherapy Devices.
Lumitex Medical Devices, Inc.
Primary
Strongsville
OH
USA
ISO 13485/CMDCAS
Design and Development, Production, Contract Manufacturing and Distribution of Sterile and Non-sterile Medical Illumination Devices and Non-sterile
Phototherapy Devices.
Lumitex, Inc
Secondary
Strongsville
OH
USA
EN ISO 13485:2012
Design and Development, Production and Distribution of Medical Illumination Devices and Phototherapy Devices.
Lumitex, Inc.
Primary
Strongsville
OH
USA
EN ISO 13485:2012
Design and Development, Production and Distribution of Medical Illumination Devices and Phototherapy Devices.
Lunarline
Single
Arlington
VA
USA
ISO 9001:2008
Lynch Medical Supplies (LMS) LTD
Single
Co. Dublin
Ireland
EN ISO 13485:2012
COMPANY
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Scope
Development and delivery of cyber security and privacy solutions to include services, training and products.
The manufacture and supply of non-sterile crepe and conforming bandages and the supply of related medical disposables.
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
M & M Qualtech Ltd
Single
M & M Qualtech Ltd.
COMPANY
Country
Scheme
Co Galway
Ireland
EN ISO 13485:2012
The Sub-Assembly manufacture, Assembly and System integration of non-invasive Medical Devices such as Printed Circuit Board Assemblies, muscle
stimulants and respiratory products: the manufacture of Medical Device interface cables, and themanufacture of invasive Refulx Control products.
Single
Co Galway
Ireland
ISO 9001:2008
The Manufacture of Electronic Products and Wiring Harnesses. Supply Chain Management: including procurement, materials management, pick/pack
ship, and customer order fulfillment
Maintech
Primary
Cranford
NJ
USA
ISO 9001:2008
IT Infrastructure Support Services
Maintech
Secondary
Wallington
NJ
USA
ISO 9001:2008
IT Infrastructure Support Services
Manufactured Packaging Products Group
Primary
Fullerton
CA
USA
ISO 9001:2008
Design and manufacturing of corrugated shipping containers, corrugated containers, preprinted and laminated corrugated containers, inserts, partitions,
display and related corrugated products.
Manufactured Packaging Products Group
Secondary
Alhambra
CA
USA
ISO 9001:2008
Design and manufacturing of corrugated shipping containers, corrugated containers, preprinted corrugated containers, labeled corrugated containers,
inserts and laminated inserts, partitions, display and related corrugated products.
Manufactured Packaging Products Group
Secondary
San Marcos
CA
USA
ISO 9001:2008
Design and manufacturing of corrugated shipping containers, corrugated containers, preprinted and laminated corrugated containers, inserts, partitions,
display and related corrugated products.
Manufactured Packaging Products Group
Secondary
Brea
CA
USA
ISO 9001:2008
Design and manufacturing of corrugated shipping containers, corrugated containers, preprinted and laminated corrugated containers, inserts, partitions,
display and related corrugated products.
Manufactured Packaging Products Group
Secondary
Newark
CA
USA
ISO 9001:2008
Design and manufacturing of corrugated shipping containers, corrugated containers, preprinted corrugated containers, labeled corrugated containers,
inserts and laminated inserts, partitions, display and related corrugated products.
Manufactured Packaging Products Group
Secondary
Union City
CA
USA
ISO 9001:2008
Design and manufacturing of corrugated shipping containers, corrugated containers, preprinted and laminated corrugated containers, inserts, partitions,
display and related corrugated products.
Manufactured Packaging Products Group
Secondary
Sycamore
IL
USA
ISO 9001:2008
Design and manufacturing of corrugated shipping containers, corrugated containers, preprinted and laminated corrugated containers, inserts, partitions,
display and related corrugated products.
Manufacturing Technology Group
Single
Westfield
MA
USA
ISO 9001:2008
Fabrication of metal goods for the commercial and industrial marketplace.
MAR COR Purification
Single
Minneapolis
MN
USA
ISO 13485/CMDCAS
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
STATE
Scope
Design, Manufacturing, Installation and Service of Solution Delivery Systems and Reverse Osmosis Systems used in Hemodialysis and Distribution of
Filter Products and Cleaners/Sterilants used in Hemodialysis including Dispensing Equipment.
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
Marathon Abrasive Company, Inc
Single
Chester
SC
USA
ISO 9001:2008
Mar-Med Co.
Single
Grand Rapids
MI
USA
EN ISO 13485:2012
The Design, Development, Manufacture and Distribution of Sterile Tourniquet Devices for Digit Surgery and Non-sterile Cast Protectors.
Marvao Medical Devices Ltd
Single
Galway
Ireland
EN ISO 13485:2012
The design and manufacture of sterile, implantable and non-implantable vascular access devices andaccessories.
Mass Design
Single
Nashua
NH
USA
ISO 13485:2003
The Fabrication and Assembly of Printed Wiring Boards for the Medical Industry.
MASS Precision, Inc.
Single
San Jose
CA
USA
ISO 9001:2008
Contract Design, Manufacturing, System Integration, Refurbishing and Testing of Metal Components, Assemblies and Electro-Mechanical Assemblies.
MASS Precision, Inc.
Single
Santa Clara
CA
USA
EN ISO 13485:2012
Masterbox
Secondary
Montebello
CA
USA
ISO 9001:2008
The Purchase and Sale of Products and Services Including Custom and Stock Packaging Products and Related Machinery and Janitorial Supplies and
Turn Key Assembly.
Masterbox
Secondary
Phoenix
AZ
USA
ISO 9001:2008
Redistribution of industrial packaging products including boxes, tapes, film, strapping, sanitary and janitorial supplies, cushioning material, jiffy bags,
stretch film, mailing tubes and kraft paper.
Single
Sutton
MA
USA
ISO 9001:2008
The manufacture of heavy gauge thermo-formed and vacuum-formed plastic parts for a variety of industries; including medical.
Primary
Turners Falls
MA
USA
ISO 9001:2008
Design, Manufacture and Distribution of hand tools.
MB MediPrint Ltd
Single
Co Sligo
Ireland
EN ISO 13485:2012
MC3, Inc.
Single
Ann Arbor
MI
USA
ISO 13485:2003
ISO 13485 Scope: Contract manufacturing of electro-mechanical devices for patient simulation and healthcare training systems.ISO9K Scope: Contract
manufacturing of electro-mechanical products, components, and assemblies.
McAfee Inc.
Single
Santa Clara
CA
USA
ISO 9001:2008
Provide database support for Consumer, Mobile and Small Business Database Operations.
COMPANY
Mayfield Plastics, Inc.
Mayhew Tools
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Scope
The design and manufacture of custom hot pressed, high speed grinding wheels.
Contract Design, Manufacturing, System Integration and Testing of Metal Components, Assemblies and Electro-Mechanical Assemblies for (Non-Sterile)
Medical Application.
The provision of printing, packaging and related services for the medical industry.ISO9k: The provision of printing, assembly, packaging and related
services to the medical and associated industries
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
McConnell Orthopedic Manufacturing Compa
Single
Greenville
TX
USA
EN ISO 13485:2012
The Manufacture and Distribution of Non-Sterile Patient Positioning and Support Devices and Related Sterile Disposable Support Wraps.
McKesson Ireland
Single
Co Cork
Ireland
EN ISO 13485:2012
ISO 13485: The Manufacture and Distribution of Healthcare Software and Web-based Programmes used for Patient Monitoring, Diagnostic and Image
Management. The Printing and Duplication of Healthcare Documentation, including Instructions for Use.ISO 9k: The Manufacture and Distribution of
Healthcare Softeware and the printing and duplication of Healthcare and other documentation
McKesson Ireland
Single
Co Cork
Ireland
ISO 9001:2008
MDI Medical Ltd.
Secondary
Belfast
Nothern Ireland
EN ISO 13485:2012
The supply, installation, maintenance, service and repair of medical instruments, systems and equipment.
MDI Medical Ltd.
Primary
Kells
Co. Meath
Ireland
EN ISO 13485:2012
The supply, installation, maintenance, service and repair of medical instruments, systems and equipment.
Medentech
Single
Wexford,
Ireland
EN ISO 13485:2012
The manufacture and distribution of disinfection agents specifically intended for disinfecting medical devices.ISO9k: The design, development,
manufacturer and packing of effervesent tablets and granuals, and the design, development and assembly of water disinfection devices
Medical Device and Implants LLC
Single
Lancaster
PA
USA
I.S.EN ISO13485:2003
Medical Predictive Science Corporation
Single
Charlottesville
VA
USA
ISO 13485/CMDCAS
Medifill Ltd.
Single
Dublin 15
Ireland
ISO 9001:2008
Medivance Inc.
Single
Louisville
USA
ISO 13485/CMDCAS
The Design, Manufacture, Servicing and Distribution of Non-Sterile Devices for Therapeutic Temperature Management.
ISO 13485/CMDCAS
The Design, Manufacture, Distribution, Installation and Service of Automatic Endoscope Reprocessing Equipment Including Leak Tester Accessories,
Sterilants and High Level Disinfectants,Dialyzer Reprocessing Systems, Hemodialysis Concentrates, Hemodialyzers, Hemofilters and Hemoconcentrators
and Service of Endoscopic Irrigation Pumps and Insufflators. Provision of hydrogen peroxide/peracetic acid contract processing services inaccordance
with ISO 14937:2009.
COMPANY
Medivators Inc.
Secondary
Minneapolis
CO
MN
USA
Scope
The Manufacture and Distribution of Healthcare Softeware and the printing and duplication of Healthcare and other documentation
The Manufacturing of Metal and Plastic Medical and Dental Implants, Appliances and Tools.
The design, manufacture and distribution of automated systems for the monitoring and evaluation of neonatal and paediatric heart rate variability.
The Manafacture and Supply of Bulk Adhesives
Medivators Inc.
Secondary
Minneapolis
MN
USA
ISO 13485/CMDCAS
The Design, Manufacture, Distribution, Installation and Service of Automatic Endoscope Reprocessing Equipment Including Leak Tester Accessories,
Sterilants and High Level Disinfectants,Dialyzer Reprocessing Systems, Hemodialysis Concentrates, Hemodialyzers, Hemofilters and Hemoconcentrators
and Service of Endoscopic Irrigation Pumps and Insufflators. Provision of hydrogen peroxide/peracetic acid contract processing services inaccordance
with ISO 14937:2009.
Medivators Inc.
Secondary
Conroe
TX
USA
ISO 13485/CMDCAS
Design and Development, Manufacture, and Distribution of Endoscopic Irrigation Pumps and Insufflators, Disposable Valves, Sterile Tubing Sets and
Accessories for Endoscopy and General Surgery.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
COMPANY
Medivators Inc.
Profile
Type
CITY
STATE
Country
Scheme
Primary
Conroe
TX
USA
ISO 13485/CMDCAS
Design and Development, Manufacture, and Distribution of Endoscopic Irrigation Pumps and Insufflators, Disposable Valves, Sterile Tubing Sets and
Accessories for Endoscopy and General Surgery.
Scope
Primary
Minneapolis
MN
USA
ISO 13485/CMDCAS
The Design, Manufacture, Distribution, Installation and Service of Automatic Endoscope Reprocessing Equipment Including Leak Tester Accessories,
Sterilants and High Level Disinfectants,Dialyzer Reprocessing Systems, Hemodialysis Concentrates, Hemodialyzers, Hemofilters and Hemoconcentrators
and Service of Endoscopic Irrigation Pumps and Insufflators. Provision of hydrogen peroxide/peracetic acid contract processing services inaccordance
with ISO 14937:2009.
Single
Minneapolis
MN
USA
ISO 13485/CMDCAS
The design, manufacture, and distribution of active manometry systems and catheters, magnetic resonance imaging accessories, and patient biofeedback
monitors.
Medtronic
Secondary
Co. Galway
Ireland
OHSAS 18001:2007
The design and manufacture of medical devices.
Medtronic
Single
Co. Galway
Ireland
OHSAS 18001:2007
The environmental aspects for the design and manufacture of Cardiology Products
Medtronic 3F Therapeutics, Inc.
Primary
Santa Ana
CA
USA
I.S.EN ISO13485:2012
The design, manufacture, and distribution of percutaneous transcatheter aortic valve bioprostheses, and related delivery systems.
Medtronic 3F Therapeutics, Inc.
Secondary
Santa Ana
CA
USA
I.S.EN ISO13485:2012
The design, manufacture, and distribution of percutaneous transcatheter aortic valve bioprostheses, and related delivery systems.
Medtronic Ablation Frontiers LLC
Single
Carlsbad
CA
USA
ISO 13485/CMDCAS
The Design and Development, Manufacture and Distribution of RF Ablation Systems, including Sterile Disposable Catheters, Sheaths and Guidewires, and
the Service of RF Ablation Instruments.
Primary
Santa Ana
CA
USA
ISO 13485/CMDCAS
MD Scope: The design, manufacture and distribution of percutaneous tissue aortic valve, delivery system, compression loading device and guide wires for
use in cardiovascular diagnostic and interventional procedures.CMDCAS Scope: The design, manufacture and distribution of percutaneous tissue aortic
valve, delivery system, compression loading device and guide wires for use in cardiovascular diagnostic and interventional procedures.
Medtronic CryoCath LP
Secondary
Pointe-Claire, Quebec
Canada
ISO 13485/CMDCAS
The Design and Development, Manufacture and Distribution of RF Ablation Systems, including Sterile Disposable Catheters, Sheaths and Guidewires and
the Service of RF Ablation Instruments.
Medtronic Mexico S. de R.L. de CV
Secondary
Baja California
Mexico
ISO 13485/CMDCAS
MD Scope: The design, manufacture and distribution of percutaneous tissue aortic valve, delivery system, compression loading device and guide wires for
use in cardiovascular diagnostic and interventional procedures.CMDCAS Scope: The design, manufacture and distribution of percutaneous tissue aortic
valve, delivery system, compression loading device and guide wires for use in cardiovascular diagnostic and interventional procedures.
Medtronic Mexico S. de R.L. de CV
Secondary
Baja California
Mexico
ISO 13485/CMDCAS
MD Scope: The design, manufacture and distribution of percutaneous tissue aortic valve, delivery system, compression loading device and guide wires for
use in cardiovascular diagnostic and interventional procedures.CMDCAS Scope: The design, manufacture and distribution of percutaneous tissue aortic
valve, delivery system, compression loading device and guide wires for use in cardiovascular diagnostic and interventional procedures.
Medtronic Mexico S. de R.L. de CV
Secondary
Baja California
Mexico
I.S.EN ISO13485:2012
The Design and Development, Manufacture and Distribution of RF Ablation Systems, including Sterile Disposable Catheters, Sheaths and Guidewires and
the Service of RF Ablation Instruments.
Medivators Inc.
Medspira LLC
Medtronic CoreValve LLC
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
Scope
Medtronic, Inc.
Secondary
Carlsbad
CA
USA
I.S.EN ISO13485:2012
The Design and Development, Manufacture and Distribution of RF Ablation Systems, including Sterile Disposable Catheters, Sheaths and Guidewires and
the Service of RF Ablation Instruments.
Medtronic, Inc.
Secondary
Mounds View
CA
USA
I.S.EN ISO13485:2012
The Design and Development, Manufacture and Distribution of RF Ablation Systems, including Sterile Disposable Catheters, Sheaths and Guidewires and
the Service of RF Ablation Instruments.
Medtronic, Inc.
Primary
Minneapolis
MN
USA
I.S.EN ISO13485:2012
The Design and Development, Manufacture and Distribution of RF Ablation Systems, including Sterile Disposable Catheters, Sheaths and Guidewires and
the Service of RF Ablation Instruments.
Megadyne Medical Products Inc.
Single
Draper
UT
USA
ISO 13485/CMDCAS
Mergon
Single
Co. Westmeath
Ireland
ISO 9001:2008
Mergon International
Single
Co. Westmeath
Ireland
EN ISO 13485:2012
MGS Manufacturing Group LTD
Single
Co. Kildare
Ireland
ISO 13485:2003
Contract Moulding and Manufacture of components for the Medical Device Industry.ISO9K: Contract Moulding of injection molded components and mould
tool maintence and repaire
Microfabrica, Inc.
Single
Van Nuys
CA
USA
ISO 13485:2003
MD 13485 only: Manufacture and distribution of miniature metal medical device parts and components.ISO 9001 only: Manufacture and distribution of
miniature metal parts and components.
MicroLan Systems, Inc.
Single
Merrimack
NH
USA
ISO 9001:2008
The configuration and production of custom industrial computer systems.
Microsemi Corporation
Single
Santa Clara
CA
USA
ISO 9001:2008
The design, prototype build and production of RF silicon bipolar, MOS, silicon carbide and gallium nitride transistors and related wafer fab operations.
Microsemi Ireland
Single
Co Clare
Ireland
AS 9100 - C
Screening and Supply of High Reliability Discrete Semiconductor Component.
Microsemi Ireland
Single
Co Clare
Ireland
ISO 14001:2004
Screening and Supply of High Reliability Discrete Semiconductor Component.
Microsoft Operations Puerto Rico, LLC
Single
Humacao
Puerto Rico
ISO 9001:2008
Manufacture of Optical Media CD/DVD ROM.
COMPANY
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
The design, manufacture, distribution and service of sterile and non-sterile medical devices for electrosurgical use.
The technical moulding and assembly of automotive, medical and industrial products.
The manufacture of blow moulded components and component assembles for the medical device industry.
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
Scope
Microteq Engineering, Inc.
Single
San Antonio
TX
USA
ISO 9001:2008
Manufacturing Facility providing Precision Machining, Sheet Metal, Fabrication, Wire Harness, Welding, Painting and Electrical/Mechanical Assemblies for
Department of Defense, Aerospace, Energy, Semiconductor and Oil Industry.
Microwave Components and Systems Inc.
Single
Northborough
MA
USA
ISO 9001:2008
Design and Manufacture of Microwave Components.
Mid-State Machine Products
Primary
Winslow
ME
USA
AS 9100 - C
Provider of machined products and related services (e.g. weld and NDE) to a customer design and specified requirement.
Mid-State Machine Products
Secondary
Waterville
ME
USA
AS 9100 - C
Provider of machined products and related services (e.g. weld and NDE) to a customer design and specified requirement.
Midwest Truck & Auto Parts, Inc.
Single
Chicago
IL
USA
ISO 9001:2008
Wholesale Supplier of Aftermarket Truck and Automotive Components and Fabricated Assemblies
Mile Hi Foods
Single
Denver
CO
USA
ISO 14001:2004
Distribution of food
Miramar Labs, Inc.
Single
Santa Clara
CA
USA
ISO 13485/CMDCAS
The Design, Manufacture, Distribution and Servicing of Microwave Energy Generation Systems, Electro-Mechanical Applicators, and related Sterile
Accessories for the treatment of Dermatologic Disorders.
Modified Polymer Components Inc.
Primary
Sunnyvale
CA
USA
EN ISO 13485:2012
Design, Development, and Manufacturing of Polymer Based Components for Medical Device and Diagnostic Applications.ISO 9001:2008 Scope: Design,
Development, and Manufacturing of Polymer Based Components for Industrial Applications
Modified Polymer Components Inc.
Secondary
Sunnyvale
CA
USA
ISO 9001:2008
Design, Development, and Manufacturing of Polymer Based Components for Industrial Applications.
Modulus Inc.
Single
San Jose
CA
USA
ISO 13485:2003
9K Scope: Contract Design, Prototyping Manufacture and Service of General Commercial Electronic Devices and Electronic Sub-Assemblies for Medical
Devices.ISO 13485 Scope: Contract Design, Development and Manufacturing of Implantable and Non-Implantable Medical Devices and Related
components and Subsystems.
Moll Industries Ireland Ltd
Single
Co. Donegal
Ireland
EN ISO 13485:2012
The manufacture, assembly and packaging of injection molded medical device components.
Monobind Inc.
Secondary
Lake Forest
CA
USA
EN ISO 13485:2012
The Design, Manufacture and Distribution of In-Vitro Diagnostic Medical Device Immunoassays, and Related Reagent Products and Equipment
Monobind Inc.
Primary
Lake Forest
CA
USA
EN ISO 13485:2012
The Design, Manufacture and Distribution of In-Vitro Diagnostic Medical Device Immunoassays, and Related Reagent Products and Equipment
COMPANY
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
Monzite d.b.a. Impellimax
Single
Nashua
NH
USA
ISO 9001:2008
Mound Laser & Photonics Center, Inc.
Single
Kettering
OH
USA
EN ISO 13485:2012
Moximed, Inc.
Single
Hayward
CA
USA
ISO 13485:2003
The design, manufacture and distribution of non-active orthopaedic implants and related instrumentation for knee osteoarthritis.
MuShield Company Inc
Single
Londonderry
NH
USA
ISO 9001:2008
The manufacture of sheet metal components with magnetic shielding properties.
Myers Controlled Power, LLC
Single
North Canton
OH
USA
ISO 9001:2008
Design, Manufacture, and Servicing of AC & DC Electrical Switchgear and Switchboards, Circuit Breakers, Bus Duct, Relay Panels, Power Control
Centers, Metered Service Pedestals, Panel Boards, Battery Analysis, Enclosures, Rectifiers, Inverters, andRelated Equipment.
Nash Manufacturing and Grinding Services
Single
Springfield
MA
USA
ISO 9001:2008
The design, manufacture and sales of precision machined components to customer requirements.
Primary
Jasper
IN
USA
ISO 9001:2008
The design, manufacture and sales of office furniture products and sub-assemblies.
National Office Furniture-Danville
Secondary
Danville
KY
USA
ISO 9001:2008
The design, manufacture and sales of office furniture products and sub-assemblies.
National Office Furniture-Fordsville
Secondary
Fordsville
KY
USA
ISO 9001:2008
The design, manufacture and sales of office furniture products and sub-assemblies.
National Office Furniture-Jasper 11th Av
Secondary
Jasper
IN
USA
ISO 9001:2008
The design, manufacture and sales of office furniture products and sub-assemblies.
National Office Furniture-Santa Claus
Secondary
Santa Claus
IN
USA
ISO 9001:2008
The design, manufacture and sales of office furniture products and sub-assemblies.
Nelipak Holdings Ireland Ltd
Single
Galway
Ireland
EN ISO 13485:2012
Neo-Shiny Industrial Corporation
Single
Taoyuan Hsien, 333
Taiwan, R.O.C.
ISO 9001:2008
COMPANY
National Office Furniture
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Scope
The Design and Manufacture of Microelectronic Assemblies.
The Manufacture, Laser MicroMachining, Laser Microcutting, Laser Welding, Laser Marking and Surface Finishing of Components and Subassemblies for
the Medical Device Industry.
MD Scope: Contract Manufacturing, Assembly, and Packaging of Medical DevicesISO9K Scope: Design, Manufacturing and Supply of Packaging for the
Healthcare, Electronic and Pharmaceutical Industries.
Design, manufacture and sales of Drying, Heat Treatment, Hot Air Ovens and UV Curing Equipment.
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
Single
neoSurgical Ltd
neoSurgical Ltd
COMPANY
Country
Scheme
Taoyuan Hsien
Taiwan, R.O.C.
ECCB Manufacture App
Primary
Galway
Ireland
EN ISO 13485:2012
The Design, Manufacture and Distribution of Suture-based Anchor Systems for Closure of Port site Defects during Edoscopic/Laproscopic Surgery.
Secondary
Dublin
Ireland
EN ISO 13485:2012
The Design, Manufacture and Distribution of Suture-based Anchor Systems for Closure of Port site Defects during Edoscopic/Laproscopic Surgery.
NeoTract, Inc.
Single
Pleasanton
CA
USA
ISO 13485/CMDCAS
The Design, Manufacture and Distribution of Implantable Medical Devices and Related Procedure Accessories in the area of Urology.
Netco Extruded Plastics, Inc.
Single
Hudson
MA
USA
ISO 9001:2008
Neurovision Medical Products, Inc.
Single
Ventura
CA
USA
ISO 13485/CMDCAS
Nobert Plating Co.
Primary
Chicago
IL
USA
AS 9100 - C
The provision of Electroless, Electroplating and Metal Finishing Services.
Nobert Plating Co.
Secondary
Chicago
IL
USA
AS 9100 - C
The provision of Electroless, Electroplating and Metal Finishing Services.
Nobert Plating Co.
Secondary
Chicago
IL
USA
AS 9100 - C
The provision of Electroless, Electroplating and Metal Finishing Services.
Nomax Inc.
Single
St. Louis
MO
USA
EN ISO 13485:2012
Norben Company, Inc.
Single
Willoughby
OH
USA
ISO 9001:2008
Distributor of Food and Chemical Ingredients for Pharmaceutical, Food/Nutrition and Electronic Industries.
Norgren Kloehn, Inc.
Single
Las Vegas
NV
USA
ISO 9001:2008
The Design and Manufacture of Fluid Handling Devices.
Primary
Camarillo
CA
USA
ISO 13485/CMDCAS
Neo-Shiny Industrial Corporation
North American Imaging
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
STATE
Scope
Design, manufacture and sales of drying, heat treatment, hot air ovens and UV curing equipment
Manufacturer and supplier of plastic extruded components to the commercial and medical device industries.
The design, manufacture, distribution and service of laryngeal surface electrodes, nerve location devices and software, surface electrodes, stimulation
instruments, and surgical devices used for nerve monitoring in head and neck surgery.
Manufacture and distribution of sterile diagnostic ophthalmic strips.
The Manufacture and Distribution of X-Ray Tube Assemblies and Image Intensifiers for Medical Imaging Systems.
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
Northern Clearing Inc.
Single
Ashland
WI
USA
ISO 14001:2004
The processes related to the management of right-of-way land clearing, reclamation, and site work (Clearing, Electrical, Dirt and Maintenance)
Northern Clearing Inc.
Single
Ashland
WI
USA
ISO 9001:2008
The processes related to the management of right-of-way land clearing, reclamation, and site work (Clearing, Electrical, Dirt and Maintenance)
Northern Clearing Inc.
Single
Ashland
WI
USA
OHSAS 18001:2007
The processes related to the management of right-of-way land clearing, reclamation, and site work (Clearing, Electrical, Dirt and Maintenance)
NovaBay Pharmaceuticals, Inc.
Single
Emeryville
CA
USA
ISO 13485:2003
Design, development, manufacture, and distribution of medical devices for skin and wound cleansing, and for contact lens cleansing.
Novariant
Single
Fremont
CA
USA
ISO 9001:2008
The Design, Manufacture, Sales and Service of Auto Steering Solutions.
Nypro
Single
Co. Wicklow
Ireland
EN ISO 13485:2012
MD Scope: The Contract Design and Development, Manufacture, Automated Assembly and Testing of Injection Moulded Components and SubAssemblies.ISO9K Scope: The contract manufacture, automated assembly and testing of injection moulded components and sub-assemblies.
Nypro Ltd
Single
Co. Waterford
Ireland
EN ISO 13485:2012
MD & ISO9K Scope: The manufacture and assembly of injection moulded medical device components.
Obalon Therapeutics, Inc
Single
Carlsbad
USA
EN ISO 13485:2003
Design, Manufacture and Distribution of Gastric Balloon Systems for Weight Loss
Ocean Springs Metal Manufacture Ltd.
Single
Guangdong
China
ECCB HSPM
Manufacture of springs and metal stampings for electrical and electronic products
OM HealthCare Logistics
Secondary
Redlands
CA
USA
I.S.EN ISO13485:2012
ISO 13485 scope: Distribution, Logistics Repackaging and Relabeling for Medical Device Companies.ISO 9001 scope: Distribution, Logistics Repackaging
and Relabeling for Medical Device and Life Science Companies.
OM HealthCare Logistics
Single
Louisville
KY
USA
I.S.EN ISO13485:2012
ISO 13485 scope: Distribution, Logistics Repackaging and Relabeling for Medical Device Companies.ISO 9001 scope: Distribution, Logistics Repackaging
and Relabeling for Medical Device and Life Science Companies.
OMG Borchers sas
Single
Castres
France
OHSAS 18001:2007
Development, production, sale and trade of additives for paints, varnishes, additives, polyester and printing inks
ON Light Sciences, Inc.
Single
Dublin
USA
EN ISO 13485:2012
The Design, Manufacture and Distribution of Gel Based Patches for use as Adjunct Therapy during Laser Removal of Cutaneous Vascular Lesions, Benign
Pigmented Lesions, and Tattoos.
COMPANY
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
CA
CA
Scope
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
Scope
Operational Technologies Corporation
Secondary
San Antonio
TX
USA
TL 9000 R5.0/5.0
ISO 9001 Scope: Supply Chain Management ServicesTL9000-V Scope: Supply Chain Management Services TL 9000 R 5.0/R 4.5 service for the following
product Categories: 7.4 Repair Service, 7.7.5.1 Logistical Service, Third Party.
Operational Technologies Corporation
Secondary
Yuma
AZ
USA
TL 9000 R5.0/5.0
ISO 9001 Scope: Supply Chain Management ServicesTL9000-V Scope: Supply Chain Management Services TL 9000 R 5.0/R 4.5 service for the following
product Categories: 7.4 Repair Service, 7.7.5.1 Logistical Service, Third Party.
Operational Technologies Corporation
Secondary
Mexico
TL 9000 R5.0/5.0
ISO 9001 Scope: Supply Chain Management ServicesTL9000-V Scope: Supply Chain Management Services TL 9000 R 5.0/R 4.5 service for the following
product Categories: 7.4 Repair Service, 7.7.5.1 Logistical Service, Third Party.
Operational Technologies Corporation
Single
San Antonio
TX
USA
TL 9000 R5.0/5.0
ISO 9001 Scope: Supply Chain Management ServicesTL9000-V Scope: Supply Chain Management Services TL 9000 R 5.0/R 4.5 service for the following
product Categories: 7.4 Repair Service, 7.7.5.1 Logistical Service, Third Party.
OPKO Diagnostics LLC
Single
Woburn
MA
USA
EN ISO 13485:2012
OpTech Enterprise Solutions, LLC
Single
San Antonio
TX
USA
TL 9000 R5.0/5.0
OptiScan Biomedical Corporation
Single
Hayward
CA
USA
ISO 13485/CMDCAS
Ortho Development Corporation
Single
Draper
UT
USA
ISO 13485:2003
The Design, Manufacture, and Distribution of Orthopaedic Implants in the area of Knee, Hip, Trauma and Spinal Reconstruction.
Ovelle Ltd
Single
Dundalk
Ireland
EN ISO 13485:2012
Design, manufacture and distribution of non-medicated skin creams and the contract manufacture of non-medicated skin creams.
Pantronix Corporation
Single
Fremont
USA
ISO 13485:2003
The assembly, packaging and reliability testing of semiconductor devices, printed circuit boards and electronic systems for medical devices.ISO 9k: The
assembly, packaging and reliability testing of semiconductor devices, printed circuit boards and electronic systems.
Parametric Technology
Secondary
Esslingen
Germany
ISO 9001:2008
The development and delivery of Technical Support for PTC software products.
Parametric Technology (UK) Ltd.
Secondary
Farnborough
United Kingdom
ISO 9001:2008
The development and delivery of technical support for PTC software products.
Parametric Technology Corp (Shanghai)
Secondary
Shanghai
China
ISO 9001:2008
The development and delivery of technical support for PTC software products.
COMPANY
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
CA
The design, development, manufacture, and distribution of in-vitro diagnostic devices including reagents, calibrators, control materials, kits, instruments,
and systems for the determination and evaluation of biomarkers in the areas of oncology andendocrinology.
TL9000-V Scope: Supply Chain Management Services for the following product categories: 7.4 Repair Service, 7.7.5.1 Logistical Service, Third
Party.ISO9K Scope: Supply Chain Management Services
The Design, Manufacturing and Distribution of Non-Implantable Blood Glucose Monitoring Systems and Related Accessories.
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
Parametric Technology GmbH
Secondary
Unterschleissheim
Parametric Technology GmbH -Sindelfingen
Secondary
Parametric Technology SA
Secondary
Aix-en-Provence, Cedex
03
Paricon Technologies Corporation
Single
Taunton
Passy-Muir, Inc.
Single
PCCW Global
COMPANY
Country
Scheme
Germany
ISO 9001:2008
The development and delivery of technical support for PTC software products.
Germany
ISO 9001:2008
The development and delivery of technical support for PTC software products.
France
ISO 9001:2008
The development and delivery of technical support for PTC software products.
MA
USA
ISO 9001:2008
Design and manufacture of high performance separable interconnection products.
Irvine
CA
USA
ISO 13485/CMDCAS
Single
Herndon
VA
USA
ISO 9001:2008
Maintenance and Operations for a Global International Broadband Data and IP services, and Customized Network Services.
Pega Precision Inc.
Single
Morgan Hill
CA
USA
ISO 9001:2008
Precision sheet metal and machining job shop specializing in prototype and production.
Peninsula Metal Fabrication
Single
San Jose
CA
USA
ISO 9001:2008
Manufacturing of Precision Sheet Metal Products and Specializing in Tubular Metal Frames.
Pentair Valves and Controls
Single
Reno
NV
USA
ISO 9001:2008
The design, manufacture and service of knife-gate and control valves.
Penumbra, Inc.
Single
Alameda
CA
USA
ISO 13485/CMDCAS
The Design, Manufacture, and Distribution of Endovascular Implants for the treatment of aneurysms, Catheters, Guidewires, Introducer Sheaths and
related accessories for Neurological and Peripheral intravascular access,diagnosis, and treatment. The Design, Manufacture, Distribution and Service of
Active Aspiration Systems and related accessories.
Percutaneous Systems, Inc.
Single
Palo Alto
CA
USA
ISO 13485/CMDCAS
The design, manufacturing and distribution of urological catheters and stents.
PerkinElmer
Secondary
North Billerica
MA
USA
ISO 14001:2004
Design, Manufacture and Distribution of Radiolabeled Specialty Chemicals, Non-labeled Analogues, Radionuclides, Microspheres, Diagnostic and
Research Detection Systems (Kits) and Reagents, Molecular Biology Kits and Reagents, and Custom Membranes Kitand Reagents
PerkinElmer
Secondary
North Billerica
MA
USA
ISO 9001:2008
Design, Manufacture and Distribution of Radiolabeled Specialty Chemicals, Non-labeled Analogues, Radionuclides, Microspheres, Diagnostic and
Research Detection Systems (Kits) and Reagents, Molecular Biology Kits and Reagents, and Custom Membranes Kitand Reagents
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
STATE
Scope
The design, manufacture and distribution of tracheostomy and ventilator swallowing and speaking valves.
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
Scope
PerkinElmer
Primary
Shelton
CT
USA
EN ISO 13485:2012
The Design, Manufacture, Distribution and Service of Chromatographic Time of Flight Mass Spectrometer Instrument, Components, Related Software and
Peripherals.
PerkinElmer
Single
Shelton
CT
USA
ISO 9001:2008
The design, development, manufacture and service of analytical instruments and systems, including associated software.
PerkinElmer
Single
Shelton
CT
USA
ISO 14001:2004
The Design, Development, Manufacture and Service of Analytical Instruments and Systems, including Associate Hardware and Consumables.
PerkinElmer
Single
Shelton
CT
USA
OHSAS 18001:2007
The Design, Development, Manufacture and Service of Analytical Instruments and Systems, including Associated Software and Consumables.
PerkinElmer
Secondary
Billerica
MA
USA
OHSAS 18001:2007
Design, manufacture and distribution of radiolabeled specialty chemicals, non-labeled analogues, radionuclies, microspheres, diagnostic and research
detection systems (kits)and reagents, molecular biology kits and reagents, and custom membranes kits and reagents.
PerkinElmer
Secondary
Branford
CT
USA
EN ISO 13485:2012
The Design, Manufacture, Distribution and Service of Chromatographic Time of Flight Mass Spectrometer Instrument, Components, Related Software and
Peripherals.
Single
Roissy CDG Cedex
France
ISO 9001:2008
PerkinElmer - LAS
Primary
Boston
USA
OHSAS 18001:2007
PerkinElmer (India) Pvt Ltd
Primary
Maharashtra
India
ISO 9001:2008
The Sales and Service of Analytical Instrumentation and Systems, Consumables and related after-sales support
PerkinElmer (India) Pvt Ltd
Secondary
Andhra Pradesh – 500
081
India
ISO 9001:2008
The Sales and Service of Analytical Instrumentation and Systems, Consumables and related after-sales support
PerkinElmer (Schweiz) AG
Single
Switzerland
ISO 9001:2008
Sale, Support and Service of PerkinElmer and OEM Instruments which are being used in Chemical and Biological Laboratories.
PerkinElmer Health Sciences B.V.
Single
TH Groningen
The Netherlands
ISO 14001:2004
Development, Production and Distribution of Reagents and Supplies for Applications in Industrial, Biomedical and Pharmaceutical Industries.
PerkinElmer Health Sciences B.V.
Single
TH Groningen
The Netherlands
OHSAS 18001:2007
Development, Production and Distribution of Reagents and Supplies for Applications in Industrial, Biomedical and Pharmaceutical Industries.
COMPANY
PerkinElmer - LabMetrix Division
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
MA
Development of Qualification service of laboratory instrumentation-Conception, development, production and calibration of measuring systems and
laboratory equipment.
Design, manufacture and distribution of radiolabeled specialty chemicals, non-labeled analogues, radionuclies, microspheres, diagnostic and research
detection systems (kits)and reagents, molecular biology kits and reagents, and custom membranes kits and reagents.
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
PerkinElmer Health Sciences B.V.
Single
TH Groningen
PerkinElmer Health Sciences, Inc.
Single
Greenville
PerkinElmer Holdings Inc.
Single
PerkinElmer Holdings Inc.,
COMPANY
Country
Scheme
The Netherlands
ISO 9001:2008
SC
USA
I.S.EN ISO13485:2012
Santa Clara
CA
USA
ISO 14001:2004
The Design, Manufacture, Distribution and Service of X-Ray Detector Panels and X-Ray Detectorsused in Industrial and Medical Digital Imaging.
Single
Santa Clara
CA
USA
OHSAS 18001:2007
The Design, Manufacture, Distribution and Service of X-Ray Detector Panels and X-Ray Detectors used in Industrial and Medical Digital Imaging
Applications.
PerkinElmer Inc.
Primary
Boston
MA
USA
ISO 14001:2004
Design, Manufacture and Distribution of Radiolabeled Specialty Chemicals, Non-labeled Analogues, Radionuclides, Microspheres, Diagnostic and
Research Detection Systems (Kits) and Reagents, Molecular Biology Kits and Reagents, andCustom Membranes Kits and Reagents.
PerkinElmer Inc.
Primary
Santa Clara
CA
USA
EN ISO 13485:2012
PerkinElmer Inc.
Primary
Boston
MA
USA
ISO 9001:2008
The Design and Manufacture of Radio Labeled Specialty Chemicals, Non-labeled Analogues, Radionuclides, Microspheres, Diagnostic and Research
Detection Systems (kits) and Reagents, Molecular Biology Kits and Reagents,and Custom Membranes, Kits and Reagents as well as Assay Development
and Compound Screening Services.
PerkinElmer Ireland Ltd
Single
Dublin
Ireland
ISO 9001:2008
Supply, Service and Support of Laboratory Equipment.
PerkinElmer Italia S.p.A.
Single
Milano
Italy
ISO 9001:2008
Trading, installation, service assistance, application support and training for laboratory instrumentation for R&D and analytical controls.Trading of related
accessories and consumable products.
PerkinElmer LAS (Germany) GmbH
Single
Germany
ISO 9001:2008
The Sales and Service of Analytical Instrumentation, Including Consumables and the Provision of Technical Education.
PerkinElmer Llantrisant
Single
Llantrisant
United Kingdom
ISO 9001:2008
The manufacture of analytical instruments and systems.
PerkinElmer Llantrisant
Single
Llantrisant
United Kingdom
ISO 14001:2004
The manufacture of analytical instruments and systems.
PerkinElmer Llantrisant
Single
Llantrisant
United Kingdom
OHSAS 18001:2007
The manufacture of analytical instruments and systems.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
STATE
Scope
Development, Production and Distribution of Reagents and Supplies for Applications in Industrial, Biomedical and Pharmaceutical Industries.
Design, manufacture and supply of specialized filter paper devices
The Design, Manufacture, Distribution and Service of Panels and Detectors for X-Ray Imaging Applications.
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
PerkinElmer Ltd.
Single
PerkinElmer SAS
Secondary
COMPANY
PerkinElmer SAS
Primary
STATE
Country
Scheme
Beaconsfield
United Kingdom
ISO 9001:2008
The design, development, installation and servicing of analytical instruments and systems including OneSource multi-vendor services.
Villepinte
France
ISO 9001:2008
Marketing and sales of scientific equipment, accessories and consumables for the research, industry, health and environmental sectors.Service provider
for maintenance, training and other related services.
France
ISO 9001:2008
Marketing and sales of scientific equipment, accessories and consumables for the research, industry, health and environmental sectors. Service provider
for maintenance, qualification, training and other related services.Commercialisation d’équipements scientifiques, d’accessoires et de consommables pour
les secteurs de la recherche, de l’industrie, de la santé et de l’environnement. Réalisation de prestations de maintenance, de qualification, de formation et
deservices associés.
Villebon SUR YVETTE
Scope
PerkinElmer Shared Services sp. z.o.o.
Single
Poland
ISO 9001:2008
The provision of order entry, receipt and processing of customer orders, service calls.
PERKINELMER SINGAPORE PTE LTD
Single
Singapore
ISO 14001:2004
Research and Development, and Manufacture of Analytical Science Instruments. Manufacture of Life Science Technology Instruments.
PERKINELMER SINGAPORE PTE LTD
Single
Singapore
OHSAS 18001:2007
Research and Development, and Manufacture of Analytical Science Instruments. Manufacture of Life Science Technology Instruments.
PerkinElmer Singapore Pte. Ltd.
Single
Singapore
ISO 9001:2008
PerkinElmer Singapore Pte. Ltd.
Single
Singapore
EN ISO 13485:2012
PerkinElmer Technologies GmbH & Co.
Single
Walluf
Germany
ISO 9001:2008
Secondary
Walluf
Germany
EN ISO 13485:2012
The Design, Manufacture, Distribution and Service of Panels and Detectors for X-Ray Imaging Applications.
Phardiag Ltd
Single
Co. Clare
Ireland
EN ISO 13485:2012
The forecasting, procurement, and distribution of pharmaceutical and in-vitro diagnostic products, and also secondary packaging of IVD products on behalf
of third parties.
PHOTONIS USA
Single
Sturbridge
MA
USA
ISO 9001:2008
The design, manufacturing, testing and sales of microchannel plates, electron multipliers, detectors and associated electronics for analytical instruments,
ion guides, electron sources, fiber optic light guides and specialty glass products.
PHOTONIS USA, Pennsylvania, Inc.
Single
Lancaster
PA
USA
ISO 9001:2008
The Design and Manufacture of Electron Tubes.
PerkinElmer Technologies GmbH & Co. KG
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
The manufacture of analytical instruments and systems.
ISO13485: The Design, Development and Manufacture of Atomic Spectroscopy, Plate Reader and Gamma Counting Instruments and Systems for Clinical
Applications and/or In Vitro Diagnostic use.ISO9K: The design, development and manufacture of analytical and detection systems
Research, development, manufacturing, assembly and distribution of digital X-Ray Detectors
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
Piconics, Incorporated
Single
Tyngsboro
MA
USA
ISO 9001:2008
Portable Therapeutix, LLC
Single
Stafford
TX
USA
ISO 13485/CMDCAS
The Manufacture and Distribution of active medical devices used for cold compression therapies.
Precision Engineering Inc.
Single
Uxbridge
MA
USA
ISO 9001:2008
The fabrication of sheet metal components and assemblies, including welding and powdercoating.
Precision Engineering Inc.
Single
Uxbrige
MA
USA
ISO 14001:2004
The fabrication of sheet metal components and assemblies, including welding and powdercoating.
Precision Rings Incorporated
Single
Indianapolis
IN
USA
AS 9100 - C
Precision Swiss Products, Inc.
Single
Milpitas
CA
USA
EN ISO 13485:2012
Precision Swiss Products, Inc.
Single
Milpitas
CA
USA
AS 9100 - C
President Titanium Co., Inc.
Single
Hanson
MA
USA
ISO 9001:2008
Pressco Ltd
Single
Dublin 11
Ireland
EN ISO 13485:2012
Pressco Ltd
Single
Dublin 11
Ireland
ISO 9001:2008
The design and manufacture, assembly and test of precision machined products.
Primary Flow Signal, Inc.
Single
Cranston
RI
USA
ISO 9001:2008
The design and manufacturing of flow measuring equipment.
ProComm Inc. of Hoopeston IL
Single
Onarga
IL
USA
ISO 9001:2008
Assembly of CB Antennas and accessories.
Professional Machine, Inc.
Single
Bellingham
MA
USA
ISO 9001:2008
The production of precision CNC machined parts from engineering prototypes to large production runs for medical, aerospace, construction and energy
industries.
COMPANY
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Scope
Manufacture and sales of custom and standard passive microelectronic components for the RF, Telecommunications, medical, military and commercial
markets.
Design and manufacture of piston and seal rings.
Contract manufacturing of non-sterile components and subassemblies for medical products.
9K Scope: Contract manufacturing of non-sterile components and subassemblies for aerospace and medical productsAS Scope: Contract manufacturing
of components and subassemblies.
The distributor of domestic-made 6AL/4V Grade 5, 6AL/4V ELI and CP-Grade 4, titanium bar, sheet and plate serving the aerospace and medical
industries.
The contract manufacture for the assembly and test of respiratory and diagnostic devices.ISO 9k - The design manufacture, assembly and test of precision
machined products.
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
COMPANY
Proxim Wireless Corporation
Profile
Type
CITY
STATE
Country
Scheme
Single
Milpitas
CA
USA
ISO 9001:2008
The design, manufacturing and marketing of wireless networking products.
Scope
PT Excelitas Technologies Batam
Secondary
Indonesia
ISO 9001:2008
Design and Manufacture of Optoelectronics Products.
PT. Excelitas Technologies Batam
Primary
Indonesia
ISO 9001:2008
Design and Manufacture of Optoelectronics Products.
PT. Excelitas Technologies Batam
Primary
Indonesia
ISO 14001:2004
Design and Manufacture of Optoelectronics Products.
PT. Excelitas Technologies Batam
Secondary
Indonesia
ISO 14001:2004
Design and Manufacture of Optoelectronics Products.
PTC Corporation
Secondary
Waterloo
ON
Canada
ISO 9001:2008
The development and delivery of Technical Support for PTC software products.
Primary
Needham
MA
USA
ISO 9001:2008
The development and delivery of technical support for PTC software products.
PTC Inc. - Ann Arbor
Secondary
Ann Arbor
MI
USA
ISO 9001:2008
The development and delivery of technical support for PTC software products.
PTC Inc. - Blaine
Secondary
Blaine
MN
USA
ISO 9001:2008
The development and delivery of technical support for PTC software products.
PTC Inc. - Fort Collins
Secondary
Fort Collins
CO
USA
ISO 9001:2008
The development and delivery of technical support for PTC software products.
PTC Japan - Tokyo
Secondary
Tokyo
Japan
ISO 9001:2008
The development and delivery of technical support for PTC software products.
PTC software (India) Pvt. Ltd.
Secondary
Pune
India
ISO 9001:2008
The development and delivery of technical support for PTC software products .
Single
Herndon
USA
TL 9000 R5.0/5.0
PTC Inc.
Pulse Communications, Inc.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
VA
ISO 9001 Scope:The Design and Manufacture of Telecommunications Equipment.TL9000-H R5.0 Scope: The Design and Manufacture of
Telecommunications Equipment for the following Hardware Product Categories: 3.2.2.1.2.1 Sonet/SDH Transport Systems, 8.2.3 High Complexity
Electronic Assemblies
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
Single
San Diego
CA
USA
ISO 9001:2008
The Research, Design and Development, Marketing, Sales, Support, Administration and Assembly of LAN products, Connectors, Broadband products
including xDHL, HPN, RF, Wireless, Telecomm products, Anntennas (for mobile phones, wireless devices,automotive), Power Products, Switchmode
Transformers and Micro Components for the Automotive, Military & Aerospace Industries.
Qioptiq GmbH
Primary
D-35614 Asslar
Germany
ISO 9001:2008
Development and Marketing of Precision Optical Products. Manufacturing of optical Components including Thin Film Surface Technology. Assembly and
Test of opto-mechanical Devices and Systems
Qioptiq Ltd
Primary
Denbighshire
United Kingdom
ISO 14001:2004
Design, development and manufacture of visual and thermal imaging electro-optical equipment, and the in-service support, tools and test equipment for
these products. Design, development and manufacture of space vehicle optical components and theapplication of non-space optical coatings.
Hungary
ISO 9001:2008
Development and Marketing of Precision Optical Products. Manufacturing of optical Components including Thin Film Surface Technology. Assembly and
Test of opto-mechanical Devices and Systems
COMPANY
Pulse Electronics
Qioptiq Optikai Rendszerek Kft
Secondary
Scope
Qioptiq Photonics GmbH & Co. KG
Single
D-85622 Feldkirchen
Germany
EN ISO 13485:2012
Qioptiq Photonics GmbH &Co KG
Primary
D-37081 Gottingen
Germany
ISO 9001:2008
Design, Manufacturing and Sales of Precision Optics and Optical-Mechanical Systems.
Qioptiq Photonics GmbH &Co KG
Secondary
D-85622 Feldkirchen
Germany
ISO 9001:2008
Design, Manufacturing and Sales of Precision Optics and Optical-Mechanical Systems.
Qioptiq Photonics GmbH &Co KG
Secondary
D-94209 Regen
Germany
ISO 9001:2008
Design, Manufacturing and Sales of Precision Optics and Optical-Mechanical Systems.
Qioptiq Photonics Limited
Single
Hamble, Hants
United Kingdom
ISO 9001:2008
The design, manufacture and sale of Fiber Optics, Lasers and Fiber Coupled Laser Systems for use in precision instrumentation.
Qioptiq Singapore Pte. Ltd.
Single
Singapore
ISO 9001:2008
Design/Development, Production and Servicing of Advanced Military and Commercial Optical and Electro-Optics Components, Assemblies and Systems.
Qioptiq Singapore Pte. Ltd.
Single
Singapore
ISO 14001:2004
Design, Development, Production and Servicing of Advanced, Military and Commercial Optical and Electro-Optics Components, Assemblies and Systems.
Qioptiq Space Technology
Secondary
Rhyl
United Kingdom
ISO 14001:2004
Design, development and manufacture of visual and thermal imaging electro-optical equipment, and the in-service support, tools and test equipment for
these products. Design, development and manufacture of space vehicle optical components and theapplication of non-space optical coatings.
Single
Northfield
USA
ISO 9001:2008
Design, manufacture and distribution of rotor vales and actuators.
Quality Controls, Inc.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
NH
Design, Manufacturing and Distribution of Precision Optics and Optical-Mechanical Systems.
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
Scope
RAD Data Communications
Single
Mahwah
NJ
USA
TL 9000 R5.0/5.0
TL9000-V Scope: Distribution, sales & technical support of access products and solutions for carriers, ISP's, cellular networks, service providers and
corporate users for the following product categories:7.1.1 Installation, 7.4 Repair Services and 7.5.1 Technical Assistance and Customer Support Centers.
Randolph Products
Single
Chicopee
MA
USA
ISO 9001:2008
Design and manufacture of coatings for the Department of Defense, OEM Industry, Wood Priming Market, Anti Slip Coatings Market and various other
Specialty Industries.
Rapid DTM, Inc.
Single
Amherst
NH
USA
ISO 9001:2008
Provision of Manufacture, Inspection and Reverse Engineering Services for all Mold Types; Fixtures: Gauges: Prototype Parts and Secondary Castings,
Based on Customer Requirements.
Rapid Machining
Single
Nashua
NH
USA
ISO 9001:2008
Proto and production machined Parts manufactured to customer’s 3D model
Rapid Sheet Metal
Single
Nashua
NH
USA
ISO 9001:2008
Low volume sheet metal parts manufactured to our customers 3D model
Rapid Wire Cable
Single
Nashua
NH
USA
ISO 9001:2008
Low volume custom cable and wire harness manufactured to customer model
RBC Medical Innovations
Secondary
Lenexa
KS
USA
EN ISO 13485:2012
The contract design, manufacture, and servicing of electro-mechanical assemblies and systems for the medical device industry.
RBC Medical Innovations
Single
Lenexa
KS
USA
EN ISO 13485:2012
The contract design, manufacture, and servicing of electro-mechanical assemblies and systems for the medical device industry.
RCD Components, Inc.
Single
Manchester
NH
USA
ISO 9001:2008
ReFlow Medical, Inc.
Single
San Clemente
CA
USA
EN ISO 13485:2012
The design, manufacture and distribution of endovascular guide catheters.
Renchel Tool Inc
Single
Putnam
CT
USA
EN ISO 13485:2012
Contract Machining and Manufacturing of Components for the Medical Device Industry.ISO 9001 Scope: Contract CNC Machining.
Resin Designs, LLC
Single
Woburn
MA
USA
ISO 9001:2008
Design, Development and Manufacture of Adhesive Materials, Preforms and Films used in Microelectronics and other Industrial Applications.
Resin Designs, LLC
Single
Newark
CA
USA
ISO 9001:2008
Design, Development and Manufacture of Adhesive Material for Electronics and Other Industrial Applications.
COMPANY
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
The Design, Manufacture, Test and Supply of Active and Passive Electronic Components and Assemblies.
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
REVA Medical, Inc.
Single
San Diego
CA
USA
EN ISO 13485:2012
RFL Electronics Inc.
Single
Boonton Township
NJ
USA
ISO 9001:2008
The design and manufacture of electronic equipment and components for communication and relaying products in the electric utilities and transportation
markets.
Rimini Street Inc.
Primary
Pleasanton
CA
USA
ISO 9001:2008
Global provision of enterprise software support services, including client onboarding; client account management; product support for vendor delivered and
client customized code; fix development and delivery; and research, development and delivery ofworldwide tax, legal and regulatory updates.
Rimini Street Inc.
Secondary
Las Vegas
NV
USA
ISO 9001:2008
Global provision of enterprise software support services, including client onboarding; client account management; product support for vendor delivered and
client customized code; fix development and delivery; and research, development and delivery ofworldwide tax, legal and regulatory updates.
RITEVE
Secondary
Heredia
Costa Rica
ISO 9001:2008
The technical inspection of vehicles.
RITEVE
Secondary
Nicoya, Guanacaste
Costa Rica
ISO 9001:2008
The technical inspection of vehicles.
RITEVE
Secondary
Barranca, Puntarenas
Costa Rica
ISO 9001:2008
The technical inspection of vehicles.
RITEVE
Secondary
Nueve Millas, Limón
Costa Rica
ISO 9001:2008
The technical inspection of vehicles.
RITEVE
Secondary
Costa Rica
ISO 9001:2008
The technical inspection of vehicles.
RITEVE
Secondary
Costa Rica
ISO 9001:2008
The technical inspection of vehicles.
RITEVE
Secondary
Costa Rica
ISO 9001:2008
The technical inspection of vehicles.
RITEVE
Secondary
Costa Rica
ISO 9001:2008
The technical inspection of vehicles.
RITEVE
Secondary
Costa Rica
ISO 9001:2008
The technical inspection of vehicles.
COMPANY
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Scope
The Design, Manufacture and Distribution of Implantable, Drug-eluting, Polymer, Resorbable Coronary Stents
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
COMPANY
Profile
Type
CITY
STATE
Country
Scheme
Scope
RITEVE
Secondary
Costa Rica
ISO 9001:2008
The technical inspection of vehicles.
RITEVE
Secondary
Costa Rica
ISO 9001:2008
The technical inspection of vehicles.
RITEVE
Secondary
Costa Rica
ISO 9001:2008
The technical inspection of vehicles.
RITEVE
Secondary
Costa Rica
ISO 9001:2008
The technical inspection of vehicles.
RITEVE
Secondary
Costa Rica
ISO 9001:2008
The technical inspection of vehicles.
RITEVE SYC
Secondary
Costa Rica
ISO 9001:2008
The technical inspection of vehicles.
RITEVE SYC
Secondary
Costa Rica
ISO 9001:2008
The technical inspection of vehicles.
RITEVE SYC
Secondary
Costa Rica
ISO 9001:2008
The technical inspection of vehicles.
RITEVE SYC
Primary
Costa Rica
ISO 9001:2008
The technical inspection of vehicles.
RockTenn-Puerto Rico, Inc.
Single
Guaynabo
PR
Puerto Rico
ISO 9001:2008
The design and manufacture of corrugated containers.
RSA, The Security Division of EMC
Primary
Bedford
MA
USA
ISO 9001:2008
Production processes for the fulfillment of software and hardware products to provide computer and internet security solutions.
RSA, The Security Division of EMC
Secondary
Co. Clare
Ireland
ISO 9001:2008
Production processes for the fulfillment of software and hardware products to provide computer and internet security solutions.
Single
Sunnyvale
USA
ISO 9001:2008
Design, manufacture, distribution, and service Wi-Fi products and technologies for internet and wireless LAN systems.
Ruckus Wireless, Inc.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
CA
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
Samsung Austin Semiconductor
Single
Austin
TX
USA
ISO 14001:2004
Wafer Fabrication and Testing
Samsung Austin Semiconductor
Single
Austin
TX
USA
OHSAS 18001:2007
Wafer Fabrication and Testing
Sauer Compressors USA
Single
Stevensville
MD
USA
ISO 9001:2008
Design, Manufacture and support of high-pressure piston compressors for industrial, offshore and naval applications.
SCA CHATEAU LA LAGUNE
Single
AQUITAINE
France
ISO 14001:2004
Vine growing, AOC wine making, packaging, storage and shipping
SchaererMedical USA, Inc.
Single
Cincinnati
OH
USA
EN ISO 13485:2012
The Manufacture and Distribution of Surgical Tables.
Schivo Precision Ltd. t/a Schivo Group
Single
Waterford
Co.
Waterford
Ireland
EN ISO 13485:2012
The manufacture, assembly and test of machined parts for use in medical devices.
Scripps Laboratories
Single
San Diego
CA
USA
ISO 9001:2008
Secondary
Superior
CO
USA
EN ISO 13485:2012
The provision of translation and publishing services for the medical device industry.
SDL International
Primary
Berkshire
United Kingdom
EN ISO 13485:2012
The provision of translation and publishing services for the medical device industry.
SDL International
Secondary
Co. Wicklow
Ireland
EN ISO 13485:2012
The provision of translation and publishing services for the medical device industry.
SDL International Belgium NV
Secondary
30001 Leuven
Belgium
EN ISO 13485:2012
The provision of translation and publishing services for the medical device industry.
SDL Multilingual Services GmbH & Co. Kg
Secondary
Stuttgart
Germany
EN ISO 13485:2012
The provision of translation and publishing services for the medical device industry.
Single
Herndon
USA
ISO 9001:2008
COMPANY
SDL Flatiron
Segovia, Inc.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
VA
Scope
Process Development, Purification, and Sales of Enzymes, Proteins, Antibodies, and Related Bio-Chemicals for In-Vitro Clinical Diagnostic and Life
Science Industries.
Design, implementation, and management of IP (internet protocol) satellite network services.
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
Primary
Reno
NV
USA
ISO 9001:2008
The design, manufacture and marketing of electronic controls, sensors, thermal control devices, control knobs, heaters and related products.
Sensing Systems Corporation
Single
New Bedford
MA
USA
ISO 9001:2008
Design and manufacture a full range of measurement products and provide measurement services to various industries
Sensys Networks, Inc.
Single
Berkeley
CA
USA
ISO 9001:2008
Design and Manufacture of Wireless Vehicle Detection Systems for the Traffic Industry.
Server Technology, Inc.
Single
Reno
NV
USA
ISO 9001:2008
The design and manufacture of remote power management technology for complex distributed computer networks.
Sheathing Technologies
Single
Morgan Hill
CA
USA
ISO 13485/CMDCAS
COMPANY
Selco Products
Scope
The design and development, manufacturing and distribution of sterile and non-sterile ultrasound probe covers; sterile procedure kits and gel-filled probe
cover, and sterile and non-sterile ultrasound coupling gel.
Environmental and reliability testing for electric and electronic products (by EIA-364, GMW3172, GR-63-CORE, IEC 60068-2, ISO 4892.3, ISO 9227, ISO
16750, JESD-22, J-STD-020D, MIL-STD-202, MIL-STD-810F, PSA B2117130, VW80101, applicable ASTM, GB/Tand ISTA standards), including Vibration
test, Mechanical shock test, Free fall test, High temperature test, Low temperature test, Temperature cyclic test, Salt spray test, Damp heat tests, Mating
and un-mating force test, Wire bending test, Tensiletest, UV test, Compression test, Thermal shock test, Abrasion resistance test and Pencil hardness
test.
ShenZhen BestJ Testing Co., Ltd
Single
Shenzhen
China
IECQ ITL
Sigurd Microelectronics Corp
Single
Hu-kou Twnshp, HsinChu County
Taiwan, R.O.C.
ECCB HSPM
Silhouette Lift
Single
Irvine
CA
USA
ISO 13485/CMDCAS
Design, manufacturer and distribution of sutures for cosmetic lift procedures.
Silver Bullet Therapeutics
Single
San Jose
CA
USA
EN ISO 13485:2012
The Design, Manufacture and Distribution of Non-Active, Implantable Bone-Fixation Devices inclusive of Elemental Silver.
Sisco Corporation
Single
Nashville
IL
USA
ISO 9001:2008
Smithstown Light Engineering
Single
Shannon
Co. Clare
Ireland
EN ISO 13485:2012
Smithstown Light Engineering
Single
Co. Clare
Ireland
ISO 14001:2004
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
The production testing of integrated circuits in wafer and package form.
The manufacture of corrugated containers.
The manufacture of precision components for the Medical Device IndustryISO9K Scope: The design and manufacture of Precision Tooling and
replacement Parts
The design and manufacture of precision tooling and replacement parts.
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
Smooth-Bor Plastics
Single
Laguna Hills
CA
USA
EN ISO 13485:2012
Design, Manufacture and Distribution of flexible plastic tubing for medical device applications.
Smooth-Bor Plastics
Secondary
Spartanburg
SC
USA
EN ISO 13485:2012
Design, Manufacture and Distribution of flexible plastic tubing for medical device applications.
Single
Bloomfield
CT
USA
EN ISO 13485:2012
The Distribution of Active Surgical, Imaging, Monitoring, and Diagnostic Medical Equipment. The Refurbishment and Distribution of Active Surgical,
Imaging, Monitoring, and Diagnostic Medical Equipment.
SOUTHERN TEXTILE CO., LTD.
Primary
Taichung City
Taiwan, R.O.C.
ISO 9001:2008
Manufacturing of OE cotton yarns and OE rayon yarns.
SOUTHERN TEXTILE CO., LTD.
Secondary
Taichung City
Taiwan, R.O.C.
ISO 9001:2008
Manufacturing of OE cotton yarns and OE rayon yarns.
Sparton Beckwood
Single
Plaistow
USA
AS 9100 - C
Spectrum Research & Testing Lab, Inc.
Single
Taoyuan County
Taiwan
IECQ ITL
Spiration, Inc.
Single
Redmond
USA
ISO 13485/CMDCAS
Spirox Corporation
Single
Hsinchu
Taiwan, R.O.C.
ISO 9001:2008
The Verification Services of ESD/Latch-Up (heating by Thermo Stream), SEM, FIB, FA and RA (Reliability Test Service) with HTOL, BLT, THB, HTSL,
HAST, TCT and Preconditioning.
Spirox Corporation
Single
Hsinchu
Taiwan, R.O.C.
IECQ ITL
The Verification Services of ESD/Latch-Up (heating by Thermo Stream), SEM, FIB, FA and RA (Reliability Test Service) with HTOL, BLT, THB, HTSL,
HAST, TCT and Preconditioning.
Sponge-Jet, Inc.
Primary
Newington
NH
USA
ISO 9001:2008
The Design, Manufacture, Service, and Distribution of Abrasive Media and Surface Preparation Equipment.
Sponge-Jet, Inc.
Secondary
Montrose
PA
USA
ISO 9001:2008
The Design, Manufacture, Service, and Distribution of Abrasive Media and Surface Preparation Equipment.
Single
Geneva
Switzerland
ISO 13485/CMDCAS
COMPANY
Soma Technology, Inc.
St. Jude Medical GVA Sàrl
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
NH
WA
Scope
Contract Manufacturer of Electro-Mechanical Assemblies for the Military, Aerospace, Semiconductor, Analytical Instrumentation and Automotive Markets.
Reliability testing of IT products, IT Peripherals, RF products, Audio / Video and related products.
Design, development, manufacture and distribution of bronchoscopic devices, delivery catheters, and related accessories for biopsy, lung volume
reduction, and the treatment of damaged and/or diseased lung.
The design, manufacture and distribution of catheter systems for percutaneous ablation for the treatment of cardiac arrhythmias.
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
Stamping Technologies, Inc.
Single
Laconia
NH
USA
ISO 9001:2008
The Manufacture of Stamped, Cold Formed, Coined and CNC Machined Metal Parts.
Standex de México S.A. de C.V.
Single
Nogales, Sonora
México
ISO 9001:2008
The Manufacture of Rotary Vane Pumps.
Primary
Paris
France
I.S.EN ISO13485:2012
SteriPack Limited
Single
Co. Offaly
Ireland
EN ISO 13485:2012
SteriPack USA (Limited) LLC
Single
Lakeland
USA
ISO 13485:2003
The Manufacture and Distribution of Healthcare Packaging, Sterilizable Health Care Packaging, and the Contract Assembly and Packaging of Medical
Devices.
Stratus Technologies
Single
Dublin 15
Ireland
ISO 9001:2008
The worldwide assembly, repair, test and logistics of critical on-line computers.
Sutron Corporation
Single
Sterling
VA
USA
ISO 9001:2008
The design and manufacture of environmental monitoring and control systems, providing real-time data collection, telemetry, control and system software
to forecast activities in the areas of hydrology,meterology and water management. Applications and services include: water supply, flood warning,
irrigation control, maximizing hydro-power production, dam safety, tidal, groundwater and many others.
Suture Ease, Inc.
Single
San Jose
CA
USA
EN ISO 13485:2012
The Design, Manufacture, and Distribution of Non-Active Laparoscopic Suturing Devices.
Symetis SA
Single
Lausanne
Switzerland
EN ISO 13485:2012
The Design, Manufacture and Distribution of Perataneous Tissue Heart Valve Prostheses and Related Delivery Catheters, Introducers and surgical
Instruments
Synchrophi Systems Ltd
Single
Co. Galway
Ireland
EN ISO 13485:2012
The design, manufacture, distribution, installation & service of a wireless ambulatory patient monitoring system.
Mexico
ISO 13485:2003
The contract manufacture of single-use medical products such as gowns, molded products & components used in medical devices industry.
Mexico
ISO 13485:2003
The contract manufacture of single-use medical products such as gowns, molded products & components used in medical devices industry.
USA
ISO 13485:2003
The design and contract manufacture of sterile and non sterile, single and multi use medical and industrial products including but not limited to gowns,
moulded and electro-mechanical products and components used in medical devices and industry
COMPANY
STENTYS S.A.
Syntech de Baja California
Syntech de Baja California
Syntech International Also dba
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
FL
Secondary Tijuana Baja California
Primary
Tijuana Baja California
Single
Irvine
CA
Scope
The design, manufacture and distribution of implantable bare-metal and drug-eluding cardiovascular stents and related delivery systems,
embolectomy/thrombectomy catherters and dialation catheters.ISO9k:The design, manufacture and distribution of, implantable bare-metal and drugeluding cardiovascular stents and related delivery systems, embolectomy/thrombectomy catherters and dialation catheters.
The manufacture and supply of both sterile and non-sterile packaging producs, contract packaging and assembley of medical devices for the healthcare
industry.
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
Synvasive Technology, Inc.
Primary
Reno
NV
USA
ISO 13485/CMDCAS
The Design, Manufacture, and Distribution of Balancing Systems and Prosthetic Implantation Instruments for Orthopaedic Surgery.
Synvasive Technology, Inc.
Primary
El Dorado Hills
CA
USA
ISO 13485/CMDCAS
The Design, Manufacture, and Distribution of Surgical Saw Blades and Instruments for Orthopaedic Surgery.
Syscom Tech
Single
Moorestown
NJ
USA
ECCB HSPM
Distribution and contract manufacturing of cable assemblies and wire harnesses, printed circuit board assemblies, industrial control panels, electronic
components and electromechanical assemblies.
Syscom Tech
Single
Moorestown
NJ
USA
ISO 9001:2008
Distribution and contract manufacturing of cable assemblies and wire harnesses, printed circuit board assemblies, industrial control panels, electronic
components and electromechanical assemblies.
Systems & Processes Engineering Corp.
Single
Austin
TX
USA
ISO 9001:2008
Design, manufacture and service of electro-mechanical equipment used in defense and commercial applications.
T.M. Electronics, Inc.
Single
Boylston
MA
USA
ISO 9001:2008
Design, Manufacture, Sales and Service of Leak, Flow and Seal Strength Test Instrumentation and Accessories.
T/C Distribution
Single
Stratford
CT
USA
ISO 14001:2004
Food Distribution Warehouse Services
T2 Biosystems Inc.
Secondary
Wilmington
MA
USA
EN ISO 13485:2012
The design, manufacture and distribution of In-Vitro Diagnostic Systems, including hardware, software, and associated reagents and controls for the
detection of Candida.
T2 Biosystems Inc.
Secondary
Worcester
MA
USA
EN ISO 13485:2012
The design, manufacture and distribution of In-Vitro Diagnostic Systems, including hardware, software, and associated reagents and controls for the
detection of Candida.
T2 Biosystems Inc.
Primary
Lexington
MA
USA
EN ISO 13485:2012
The design, manufacture and distribution of In-Vitro Diagnostic Systems, including hardware, software, and associated reagents and controls for the
detection of Candida.
Single
Lincoln
RI
USA
ISO 9001:2008
Technicolor Digital Delivery Group
Secondary
Edegem
Belgium
TL 9000 R5.0/5.0
TL9000-HS Scope: Design and Development, Marketing and Sales of Modems, Gateways and Terminals for Residential and enterprise Applications ofr
the Product Category 6.2.3.1 Wired Data Modems
Technicolor Digital Delivery Group
Secondary
Indianapolis
USA
TL 9000 R5.0/5.0
TL9000-HS Sccope: Design and Development, Marketing and Sales of Modems, Gateways and Terminals for Residential and enterprise Applications ofr
the Product Category 6.2.3.1 Wired Data Modems
COMPANY
Tanury Industries
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
IN
Scope
The provision of electroplating and precious metal finishing services.
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
Technicolor Digital Delivery Group
Secondary
Technicolor Digital Delivery Group
COMPANY
Country
Scheme
Beijing
China
TL 9000 R5.0/5.0
TL9000-HS Scope: Design and Development, Marketing and Sales of Modems, Gateways and Terminals for Residential and enterprise Applications ofr
the Product Category 6.2.3.1 Wired Data Modems
Secondary
Hong Kong S.A.R.
China
TL 9000 R5.0/5.0
TL9000-HS Scope: Design and Development, Marketing and Sales of Modems, Gateways and Terminals for Residential and enterprise Applications ofr
the Product Category 6.2.3.1 Wired Data Modems
Technicolor Digital Delivery Group
Secondary
Shen Zhen
China
TL 9000 R5.0/5.0
TL9000-HS Scope: Design and Development, Marketing and Sales of Modems, Gateways and Terminals for Residential and enterprise Applications ofr
the Product Category 6.2.3.1 Wired Data Modems
Technicolor Digital Delivery Group
Primary
Issy-les-Moulineaux
Cedex
France
TL 9000 R5.0/5.0
TL9000-HS Scope: Design and Development, Marketing and Sales of Modems, Gateways and Terminals for Residential and enterprise Applications for
the Product Category 6.2.3.1 Wired Data Modems
TEK Microsystems, Inc.
Single
Chelmsford
MA
USA
ISO 9001:2008
Designs, manufactures and delivers high performance signal acquisition, generation, processing and recording products for embedded real time computer
systems, including integration of Tekmicro and third party products into turnkey platforms andsystems.
Teledyne Instruments Leeman Labs
Single
Hudson
NH
USA
ISO 9001:2008
Design, Development, Installation and Service of Analytical Instruments for Spectroscopy and Elemental Analysis.
Teledyne Judson Technologies
Single
Montgomeryville
PA
USA
ISO 9001:2008
The research, design, development, and manufacture of custom and standard high performance Focal Plane Arrays (FPA’s), Infrared Detectors and
Integrated Dewar Cooler Assemblies (IDCA’s) for the Instrumentation, Military and Space markets.
Teleflex Medical
Single
Co. Limerick
Ireland
EN ISO 13485:2012
Teleplan International
Primary
Roseville
CA
USA
ISO 14001:2004
Provide screening, repair and logistics services on computer peripheral equipment and information technology products.
Teleplan International
Primary
Roseville
CA
USA
ISO 9001:2008
Provide screening, repair and logistics services on computer peripheral equipment and information technology products.
Teleplan International
Secondary
Roseville
CA
USA
ISO 9001:2008
Provide screening, repair and logistics services on computer peripheral equipment and information technology products.
Teleplan International
Secondary
Lincoln
CA
USA
ISO 9001:2008
Provide screening, repair and logistics services on computer peripheral equipment and information technology products.
Teleplan International
Secondary
Roseville
CA
USA
ISO 14001:2004
Provide Screening, Repair and Logistics Services on computer Peripheral Equipment and Information Technology Products.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
STATE
Scope
The design and manufacture of precision tubing, components, sterile percutaneous introducer kits and catheters for distribution and for OEM
Manufacturers.
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
Secondary
Lincoln
CA
USA
ISO 14001:2004
Provide Screening, Repair and Logistics Services on Computer Peripheral Equipment and Information Technology Products.
Primary
Minneapolis
MN
USA
ISO 9001:2008
The Design, Manufacture, Sales, & Service of Industrial Indoor & Outdoor Cleaning Equipment.
Teradyne ATE
Secondary
Heredia
Costa Rica
ISO 9001:2008
Process Design, Manufacturing, Installation and Servicing Support of Automatic Test Equipment from New Product Conception through Mature Production.
Teradyne ATE
Secondary
Agoura Hills
CA
USA
ISO 9001:2008
Process Design, Manufacturing, Installation and Servicing Support of Automatic Test Equipment from New Product Conception through Mature Production.
Teradyne ATE
Primary
North Reading
MA
USA
ISO 9001:2008
Process Design, Manufacturing, Installation and Servicing Support of Automatic Test Equipment from New Product Conception through Mature Production.
Teradyne ATE
Secondary
Singapore
ISO 9001:2008
Process Design, Manufacturing, Installation and Servicing Support of Automatic Test Equipment from New Product Conception through Mature Production.
Teradyne STG
Single
North Reading
USA
AS 9100 - C
Secondary
Suzhou, Jiangsu
China
ISO 9001:2008
Process Design, Manufacturing, Installation and Servicing Support of Automatic Test Equipment from New Product Conception through Mature Production.
Teradyne, Inc.
Single
Buffalo Grove
IL
USA
ISO 9001:2008
Manufacture and Supply of Automated Test Equipment for the Semiconductor Industry.
Teradyne, Inc.
Single
North Reading
MA
USA
ISO 14001:2004
Process Design, Assembly, Repair and Servicing of Test Equipment from New Product Conception through Mature Production.
The Carlyle Johnson Machine Co., LLC
Single
Bolton
CT
USA
ISO 9001:2008
The Design and Manufacture of Electromagnetic, Mechanical, Air and Hydraulic Clutches and Brakes, and Related Devices.
The Columbia Group
Single
Panama City Beach
FL
USA
ISO 9001:2008
Design, Fabrication and Testing of Military Systems, Ocean Submersibles, Remote Operated Vehicles and Related Equipment
The Henry Perkins Company
Single
Bridgewater
MA
USA
ISO 9001:2008
The Manufacture of Gray, Ductile and Wear-resistant Iron Castings.
COMPANY
Teleplan International
Tennant Company
Teradyne Suzhou Suzhou
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
MA
Scope
Manufacturer of In-circuit and Functional Automated Test Equipment for Commercial, Military, and Aerospace Industries.
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
The Seaberg Company, Inc.
Single
Wilsonville
OR
USA
ISO 13485/CMDCAS
The UND Aerospace Foundation
Single
Grand Forks
ND
USA
ISO 9001:2008
Thermedx LLC
Single
Solon
OH
USA
ISO 13485/CMDCAS
The design, manufacture and distribution of active warming systems for infusion and irrigation and related accessories.
Thermo Fisher Scientific
Primary
Sunnyvale
CA
USA
ISO 13485/CMDCAS
The Manufacture and Distribution of In-Vitro Diagnostic Devices and Reagents for the Detection of Vitamin D Deficiency.
Thermo Fisher Scientific
Secondary
Sunnyvale
CA
USA
ISO 13485/CMDCAS
The Manufacture and Distribution of In-Vitro Diagnostic Devices and Reagents for the Detection of Vitamin D Deficiency.
Thermo Scientific Portable Analytical
Single
Tewksbury
MA
USA
ISO 9001:2008
Design, Manufacture and Distribution of Portable Analytical Instruments
Thorlabs Quantum Electronics
Single
Jessup
MD
USA
ISO 9001:2008
Designs, develops, manufactures, and provides repair services for advanced semiconductor and Lithium Niobate optical components, subsystems, and
devices for the photonics market.
THS International, Inc
Single
Indianapolis
IN
USA
ISO 13485/CMDCAS
Tool and Plastic Company Ltd
Single
Co. Longford
Ireland
ISO 9001:2008
Manufacture and assembly of plastic components for the medical device and healthcare sector.
Tool and Plastic Company Ltd
Single
Ireland
EN ISO 13485:2012
Manufacture and assembly of plastic components for the medical device and healthcare sector.
Tornier Orthopedics Ireland Ltd
Single
Co. Cork
Ireland
EN ISO 13485:2012
The manufacture and packaging of sterile orthopedic implants and related instrumentation
Transitions Optical, Inc.
Single
Pinellas Park
FL
USA
ISO 14001:2004
Translational Research Institute (TRI)
Single
Gilbert
AZ
USA
EN ISO 13485:2012
COMPANY
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Longford
Scope
The Design, Manufacture and Distribution of Orthopaedic Appliances, Supplies and Wound Care Devices.
Developing and conducting training programs, research and development, custom software development and consulting services related to the aerospace
industry.
The Design, Manufacture and Distribution of Disposable Urologic Catheters and Stone Control Devices.
The design and development of photochromic technology and the photochromic treatment of lenses for the global opthalmic market.
The Design, Manufacture and Distribution of non-active catheters for cardiovascular infusion.
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
Transpire, Inc.
Single
Gig Harbor
WA
USA
ISO 9001:2008
Develop and deliver software solutions, provides software related training, and provides engineering services (utilizing the software) to accurately predict
the macroscopic behaviour of radiation
Trend Technologies Mullingar Ltd.
Single
Co. Westmeath
Ireland
ISO 14001:2004
The manufacture and assembly of precisiom plastic injection mouldings.
Trend Technologies Mullingar Ltd.
Single
Co. Westmeath
Ireland
ISO 9001:2008
The manufacture and assembly of precisiom plastic injection mouldings.
TriVascular, Inc.
Single
Santa Rosa
CA
USA
ISO 13485/CMDCAS
TROY Group, Inc.
Single
Wheeling
WV
USA
ISO 9001:2008
COMPANY
Scope
The design, manufacture and distribution of implantable devices for the treatment of descending thoracic aneurysm, abdominal aortic aneurysm and
related delivery devices and accessories.
The design, development, manufacture, service and technical support of MICR and specialty printing supplies, printer solutions and the qualification and
manufacturing of secure digital printing systems
Trulife
Secondary
Dublin 24
Ireland
EN ISO 13485:2012
The design, manufacture and customer support of silicone and foam breast prostheses, antidecubitis products and operating room theatre supports.
Trulife
Primary
Dublin 24
Ireland
EN ISO 13485:2012
The design, manufacture and customer support of silicone and foam breast prostheses, antidecubitis products and operating room theatre supports.
Turner Medical Inc.
Single
Athens
AL
USA
ISO 13485:2003
Typenex Medical LLC
Single
Chicago
IL
USA
EN ISO 13485:2012
U-Media Communications, Inc.
Primary
Hsinchu City
Taiwan, R.O.C.
TL 9000 R5.0/5.0
TL 9000-H Scope: Design and Manufacture of Wireless Access Point (AP)/ Router/Bridge/Adaptor, Digital Multimedia Adaptor/Player/Server Product for
the following service category: 6.2.4 Digital Data Service Units.QMS Scope: Design and Manufacture of Wireless Access Point
(AP)/Router/Bridge/Adaptor, Digital Multimedia Adaptor/Player/Server.
U-Media Communications, Inc.
Secondary
Hukou
Taiwan
TL 9000 R5.0/5.0
TL 9000-H Scope: Design and Manufacture of Wireless Access Point (AP)/ Router/Bridge/Adaptor, Digital Multimedia Adaptor/Player/Server Product for
the following service category: 6.2.4 Digital Data Service Units.QMS Scope: Design and Manufacture of Wireless Access Point
(AP)/Router/Bridge/Adaptor, Digital Multimedia Adaptor/Player/Server
UNICOR Federal Prison Industries
Single
Victorville
CA
USA
ISO 9001:2008
The rebuilding and servicing of vehicles and related components.
UNICOR Federal Prison Industries, Inc.
Single
Petersburg
VA
USA
ISO 9001:2008
The Manufacture and Production of Government and Bound Paper Products.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
The contract manufacture and supply of components and assemblies used in the medical industry
The design, manufacture and distribution of blood sampling and dispensing accessories for use during In-Vitro diagnostic testing.
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
UNICOR Federal Prison Industries, Inc.
Single
Bastrop
TX
USA
ISO 9001:2008
Manufacture and installation of vehicular up-fit installation products.
UNICOR Federal Prison Industries, Inc.
Single
Texarkana
TX
USA
ISO 9001:2008
The production of air conditioning filters.
UNICOR Federal Prison Industries, Inc.
Single
Sandstone
MN
USA
ISO 9001:2008
Manufacturer of Printed Products.
UNICOR Federal Prison Industries, Inc.
Single
Miami
FL
USA
ISO 9001:2008
Manufacture of textile clothing/products.
UNICOR Federal Prison Industries, Inc.
Single
Lexington
KY
USA
ISO 9001:2008
The manufacture of cables and printed circuit boards.
UNICOR Federal Prison Industries, Inc.
Single
Jesup
GA
USA
ISO 9001:2008
Manufacture of textile clothing/products.
UNICOR Federal Prison Industries, Inc.
Single
Florence
CO
USA
ISO 9001:2008
Manufacture and assembly of office furniture.
UNICOR Federal Prison Industries, Inc.
Single
White Deer
PA
USA
ISO 9001:2008
Manufacture and assembly of office furniture.
UNICOR Federal Prison Industries, Inc.
Single
Ashland
KY
USA
ISO 9001:2008
Manufacture and assembly of office furniture.
UNICOR Federal Prison Industries, Inc.
Single
Terminal Island
CA
USA
ISO 9001:2008
Manufacture, assembler and shipper of metal and industrial products.
UNICOR Federal Prison Industries, Inc.
Single
Anthony
TX
USA
ISO 9001:2008
Service and delivery of vehicular up-fit installation products.
UNICOR Federal Prison Industries, Inc.
Single
Beaver
WV
USA
ISO 9001:2008
Manufacture and assembly of office furniture.
UNICOR Federal Prison Industries, Inc.
Single
Milan
MI
USA
ISO 9001:2008
Manufacture and assembly of office furniture.
COMPANY
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Scope
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
UNICOR Federal Prison Industries, Inc.
Single
Coleman
FL
USA
ISO 9001:2008
Manufacture and assembly of office products.
UNICOR Federal Prison Industries, Inc.
Single
Lompoc
CA
USA
ISO 9001:2008
The Manufacture of Industrial Sign Products.
UNICOR Federal Prison Industries, Inc.
Single
Forrest City
AR
USA
ISO 9001:2008
Manufacture and Assembly of Office Furniture.
UNICOR Federal Prison Industries, Inc.
Single
Minersville
PA
USA
ISO 9001:2008
Manufacture and assembly of office furniture.
UNICOR Federal Prison Industries, Inc.
Single
Pennington Gap
VA
USA
ISO 9001:2008
Manufacture of textile clothing/products.
UNICOR Federal Prison Industries, Inc.
Single
Butner
NC
USA
ISO 9001:2008
Manufacture of textile clothing/products.
UNICOR Federal Prison Industries, Inc.
Single
Waseca
MN
USA
ISO 9001:2008
The Manufacture of Clothing and Textile Products
UNICOR Federal Prison Industries, Inc.
Single
Edgefield
SC
USA
ISO 9001:2008
Manufacture of textile clothing/products.
UNICOR Federal Prison Industries, Inc.
Single
Inez
KY
USA
ISO 9001:2008
Textile Manufacturing
UNICOR Federal Prison Industries, Inc.
Single
Ray Brook
NY
USA
ISO 9001:2008
Manufacture of Textile Products.
UNICOR Federal Prison Industries, Inc.
Single
Yazoo City
MS
USA
ISO 9001:2008
Manufacture of Textile Clothing/Products.
UNICOR Federal Prison Industries, Inc.
Single
Butner
NC
USA
ISO 9001:2008
The manufacture of industrial products for governmental agencies
UNICOR Federal Prison Industries, Inc.
Single
Pekin
IL
USA
ISO 9001:2008
Design and fabrication of governmental industrial metal products.
COMPANY
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Scope
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
UNICOR Federal Prison Industries, Inc.
Single
Memphis
TN
USA
ISO 9001:2008
Manufacture of Electrical Cables for Governmental Agencies.
UNICOR Federal Prison Industries, Inc.
Single
Loretto
PA
USA
ISO 9001:2008
The manufacturer of electronic cable assemblies and installation kits.
UNICOR Federal Prison Industries, Inc.
Single
Fairton
NJ
USA
ISO 9001:2008
Manufacture of Cable Assemblies, Wiring Harnesses, Battery Boxes and Injection Molding (Rubber and Plastic).
UNICOR Federal Prison Industries, Inc.
Single
Glenville
WV
USA
ISO 9001:2008
The rebuilding and servicing of vehicles and related components
UNICOR Federal Prison Industries, Inc.
Single
Butner
NC
USA
ISO 9001:2008
Manufacture of textile clothing/products.
UNICOR Federal Prison Industries, Inc.
Single
Marion
IL
USA
ISO 9001:2008
Manufacture of electronic cable assemblies and wiring harnesses
UNICOR Federal Prison Industries, Inc.
Single
Littleton
CO
USA
ISO 9001:2008
The Manufacture of Clothing/Textile products.
UNICOR Federal Prison Industries, Inc.
Single
Leavenworth
KS
USA
ISO 9001:2008
The Manufacture and Production of Printed and Bound Paper Products.
UNICOR Federal Prison Industries, Inc.
Single
EL RENO
OK
USA
ISO 9001:2008
Sheet metal fabrication
UNICOR Federal Prison Industries, Inc.
Single
Danbury
CT
USA
ISO 9001:2008
The manufacture and assembly of Electronic Components
UNICOR Federal Prison Industries, Inc.
Single
Pollock
LA
USA
ISO 9001:2008
The Manufacture of Clothing and Textiles.
Unilife Medical Solutions, Inc.
Single
York
PA
USA
EN ISO 13485:2012
The Design and Development, Manufacture, and Distribution of Sterile Safety Syringes, Ready to Fill Syringe Components, and Active and Non-Active
Drug Injection Systems.
Unimed Surgical Products, Inc.
Single
Largo
FL
USA
EN ISO 13485:2012
Manufacture and packaging of sterile and non-sterile electrosurgical instruments.
COMPANY
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Scope
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
Unisys Corporation
Single
Irvine
CA
USA
ISO 14001:2004
Supply Chain Operation that Provides Order Fulfillment, Mechanical Assembly and Test, Drop ship and Logistics Activities for Unisys Enterprise-class
Server Products and Services.
Unisys Corporation
Single
Irvine
CA
USA
ISO 9001:2008
Suppy Chain Operation that Provides Order Fulfillment, Mechanical Assembly and Test, Drop Ship and Logistics Activities for Unisys Enterprise-class
Server Products and Services.
United Drug
Single
Co Mayo
Ireland
ISO 9001:2008
The Wholesaling and distribution of pharmaceutical products, distribution of consumer products and the supply of medical equipment and consumables
United Drug Plc
Single
Dublin 24
Ireland
ISO 9001:2008
The distribution of pharmaceuticals, consumer products, cosmetic, photographic and medical equipment. The servicing of medical equipment.
US Endodontics
Single
Johnson City
TN
USA
EN ISO 13485:2003
The Manufacture and Distribution of Endodontic Obturators, Verifiers and Dental Rotary Files.
Vander-Bend Manufacturing
Secondary
Sunnyvale
CA
USA
EN ISO 13485:2012
ISO 9001 Scope: Contract Manufacture of Precision Sheet Metal Products, Precision Machined Components, Electromechanical Assemblies including
Cable Harnesses.ISO 13485 Scope: Contract Manufacture of Precision Sheet Metal Products, Precision Machined Components, Electromechanical
Assemblies including Cable Harnesses integrated into Medical Devices.
Vander-Bend Manufacturing
Secondary
Sunnyvale
CA
USA
EN ISO 13485:2012
ISO 9001 Scope: Contract Manufacture of Precision Sheet Metal Products, Precision Machined Components, Electromechanical Assemblies including
Cable Harnesses.ISO 13485 Scope: Contract Manufacture of Precision Sheet Metal Products, Precision Machined Components, Electromechanical
Assemblies including Cable Harnesses integrated into Medical Devices.
Vander-Bend Manufacturing
Primary
Sunnyvale
CA
USA
EN ISO 13485:2012
ISO 9001 Scope: Contract Manufacture of Precision Sheet Metal Products, Precision Machined Components, Electromechanical Assemblies including
Cable Harnesses.ISO 13485 Scope: Contract Manufacture of Precision Sheet Metal Products, Precision Machined Components, Electromechanical
Assemblies including Cable Harnesses integrated into Medical Devices.
Vander-Bend Manufacturing
Secondary
Santa Clara
CA
USA
EN ISO 13485:2012
ISO 9001 Scope: Contract Manufacture of Precision Sheet Metal Products, Precision Machined Components, Electromechanical Assemblies including
Cable Harnesses.ISO 13485 Scope: Contract Manufacture of Precision Sheet Metal Products, Precision Machined Components, Electromechanical
Assemblies including Cable Harnesses integrated into Medical Devices.
Vander-Bend Manufacturing
Secondary
Sunnyvale
CA
USA
EN ISO 13485:2012
ISO 9001 Scope: Contract Manufacture of Precision Sheet Metal Products, Precision Machined Components, Electromechanical Assemblies including
Cable Harnesses.ISO 13485 Scope: Contract Manufacture of Precision Sheet Metal Products, Precision Machined Components, Electromechanical
Assemblies including Cable Harnesses integrated into Medical Devices.
VarData LLC
Single
Rochester
NY
USA
ISO 9001:2008
Varian Medical Systems, Inc.
Single
Atlanta
GA
USA
ISO 13485/CMDCAS
The Design, Manufacture, Distribution, Installation and Service of Medical Imaging Software for Radiation Therapy and Oncology.
Vasorum Ltd.
Single
Dublin 24
Ireland
EN ISO 13485:2012
The design, manufacture and distribution of minimally invasive, non-active devices for closure of vascular punctures
COMPANY
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Scope
Reseller of technology for voice, data and storage networks for both enterprise and service providers.
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
Velco Tool & Die, Inc
Primary
Lake Forest
CA
USA
ISO 13485:2003
Manufacture of plastic and metal components for the medical device industry.
Velco Tool & Die, Inc
Secondary
Lake Forest
CA
USA
ISO 13485:2003
Manufacture of plastic and metal components for the medical device industry.
Velocity Electronics
Single
Austin
TX
USA
AS 9120:2009
The inspection, storage, and distribution of electronic components and related products and the performance of supply chain solutions.
Velocity Electronics, LP
Single
Austin
TX
USA
ISO 14001:2004
The inspection, storage, and distribution of electronic components and related products and the performance of supply chain solutions.
Velocity Electronics, LP
Single
Austin
TX
USA
OHSAS 18001:2007
The inspection, storage, and distribution of electronic components and related products and the performance of supply chain solutions.
Vermont Circuits, Inc.
Single
Brattleboro
VT
USA
AS 9100 - C
Veryan Medical LTD
Single
Co. Galway
Ireland
EN ISO 13485:2012
COMPANY
Scope
The Manufacture of Printed Circuit Boards.23
The design, development and manufacture of non-active, implantable and non-implantable, peripheral and coronary vascular devices and related delivery
systems.
Volt Workforce Solutions
Primary
Orange
CA
USA
ISO 9001:2008
Provision of temporary staffing solutions
Volt Workforce Solutions
Secondary
Scottsdale
AZ
USA
ISO 9001:2008
Provision of temporary staffing solutions
Volt Workforce Solutions
Secondary
Raleigh
NC
USA
ISO 9001:2008
Provision of temporary staffing solutions
Wallac Oy
Secondary
Waltham
MA
USA
EN ISO 13485:2012
The design and manufacture of in-vitro diagnostic test kits, in-vitro diagnostic reagents, in-vitro diagnostic analysers used in the diagnosis and
management of cancer, neonatal screening, pre-natal screening, endocrine disorders,autoimmune diseases, diabetes, anaemia, infectious diseases and
disease status.
Wallac Oy
Single
Turku
Finland
ISO 9001:2008
The design and manufacture of in-vitro diagnostic test kits, in-vitro diagnostic reagents, in-vitro diagnostic analysers used in the diagnosis and
management of cancer, neonatal screening, pre-natal screening, endocrine disorders,autoimmune diseases, diabetes, anaemia, infectious diseases and
disease status.
Wallac Oy
Single
Turku
Finland
ISO 13485/CMDCAS
The design and manufacture of in-vitro diagnostic test kits, in-vitro diagnostic reagents, in-vitro diagnostic analysers used in the diagnosis and
management of cancer, neonatal screening, pre-natal screening, endocrine disorders,autoimmune diseases, diabetes, anaemia, infectious diseases and
disease status.
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
Wallac Oy, PerkinElmer Oy
Single
Wallac Oy, PerkinElmer Oy
COMPANY
Country
Scheme
Turku
Finland
OHSAS 18001:2007
Single
Turku
Finland
ISO 14001:2004
Research, product development, production, dosmestics sales and service, and technical support of instruments, reagents and software in the business
areas of analytical and diagnostic systems.
Waterford Intellectual Disability
Single
Co Waterford
Ireland
ISO 9001:2008
The provision of intellectual disability services, including residential care, respite care and day services
West Point Products, LLC.
Single
Washington
PA
USA
ISO 9001:2008
Warehousing and Distribution of Laser, Inkjet, Impact Printer Cartridges and Other Printing Consumables.
WestFab Manufacturing
Single
Santa Clara
CA
USA
ISO 9001:2008
Manufacture of precision sheet metal, machining and assemblies.
Whitman Products
Single
North Andover
MA
USA
ISO 9001:2008
Contract manufacturer of Electronic Assemblies, servicing the Instrumentation Commercial, Military, Telecommunications, RF, Medical, Industrial and
Automotive Industries.
Winchester Laboratories, LLLP
Single
Riviera Beach
FL
USA
ISO 13485/CMDCAS
WKK Technology Ltd
Single
Guangdong,
P.R. China
ECCB HSPM
Wolfe Tory Medical Inc.
Single
Salt Lake City
UT
USA
ISO 13485/CMDCAS
WONIK Quartz International Corporation
Single
Albuquerque
NM
USA
ISO 9001:2008
The manufacture of Quartz glassware for the semiconductor fabrication industry.
Xandex, Inc.
Single
Petaluma
CA
USA
ISO 9001:2008
The Design, Development and Manufacture of Test and Assembly Equipment for the Semiconductor Industry and Products for the Renewable Energy
Industry.
Xcaper Industries, LLC
Single
Irvine
CA
USA
ISO 9001:2008
The manufacture of moist direct contact filter and mask for smoke, gas protection, particulate matter and vapors from smoke.
Xeridiem Medical Devices
Single
Tucson
AZ
USA
ISO 13485/CMDCAS
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
STATE
Scope
Research, product development, production, domestic sales and service, and technical support of instruments, reagents and software in the business
areas of analytical and diagnostic systems.
Manufacture and distribution of sterile saline for topical use.
Design and manufacture of computers, telecommunication terminal products and printed circuit board assemblies (electronic products).Manufacture of
children electronic educational products.
The design, manufacture and distribution of esophageal intubation detector devices, sterile and non-sterile mucosal and serosa atomization devices,
sterile wound irrigation devices, and contract manufacturing of medical devices.
The Design and Development, Manufacture, and Distribution of Packaged Sterile and Bulk Non-Sterile Catheters, Tubing and Tubing Sets, Drainage
Devices, and Stoma Devices for Cardiovascular, Peripheral, Urological, and Enteral Feeding Applications,Surgical Instruments and Cardiac Leads.
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015
Profile
Type
CITY
STATE
Country
Scheme
Xhale Assurance, Inc
Single
Glastonbury
CT
USA
ISO 13485/CMDCAS
The Design, Development, Manufacture, Servicing and Distribution of Monitors and Sensors for Pulse Oximetry and Respiratory Rate.
Xhale Smart, Inc
Single
Gainesville
FL
USA
EN ISO 13485:2003
Design, Development, and Manufacturing of Drug Adherence Monitoring Systems.
Ximedica, LLC
Single
Providence
RI
USA
EN ISO 13485:2012
The provision of product design, engineering and contract manufacturing services for medical device customers. Assembly and packaging of electromechanical capital medical devices and assembly, packaging of sterile/non-sterile medical disposables.
XLA Inc.
Single
Springfield
VA
USA
ISO 9001:2008
Corporate management services for employee time keeping, payroll, and invoicing relating to the supply of program management, engineering and
technical, and international mission-support services across a variety of Government and commercialcontracts.
Yealy Optic Electronic Co., Ltd.
Single
Taichung City
Taiwan, R.O.C.
ISO 9001:2008
LED Visual Detection Service for LED Display and LED Lighting Device Industries.
Yealy Optic Electronic Co., Ltd.
Single
Taichung City
Taiwan, R.O.C.
ECCB Manufacture App
LED Visual Detection Service for LED Display and LED Lighting Device Industries
YSI, Inc.
Primary
Yellow Springs
OH
USA
ISO 13485/CMDCAS
The design, manufacture and service of glucose and lactate monitoring instruments and reagents used in medical applications.
YSI, Inc.
Secondary
Yellow Springs
OH
USA
ISO 13485/CMDCAS
The design, manufacture and service of glucose and lactate monitoring instruments and reagents used in medical applications.
Yuasa Battery, Inc.
Single
Laureldale
PA
USA
ISO 9001:2008
The design, manufacture and distribution of lead acid batteries and accessories.
Zhone Technologies, Inc.
Single
Largo
FL
USA
ISO 9001:2008
Manufacture and service of electronic telecommunications equipment.
Ziehl-Abegg, Inc.
Single
Greensboro
NC
USA
ISO 9001:2008
The assembly and distribution of axial and centrifugal fans and external rotor motors.
COMPANY
** To confirm the validity of certifications,
suspended or withdrawn, please contact NSAI at 603-882-4412
Scope
Single - Individual Certification
Primary - Multisite Headquaters
Secondary - Multisite Facility
1/28/2015