1. No category

Declaration of Conformity
PRODUCT IDENTIFICATION
Product name
Model/number
ECG Cables
BIOECG.
MANUFACTURER
Name of company
Address
Representative
Biogenesis S.R.L.
Edificio Plaza Mayor, Plaza
Independencia 831|607 Zip:
11.100, Montevideo - Uruguay
Tel: +598 2 904 7868
[email protected]
Mr. Jorge Villardino
AUTHORIZED
REPRESENTATIVE
Name of company
Address
CMC Medical Devices &
Drugs S.L
Spain
Telephone/email
CMC Medical Devices & Drugs S.L.
C/ Horacio Lengo Nº18, CP 29006,
Málaga-Spain
Tel: +34951214054, Fax:
+34952330100
[email protected]
CONFORMITY
ASSESSMENT
Device classification
Route to compliance
Class 1
Rule 12
Annex VII of MDD 93/42/EEC Council Directive
Biogenesis S.R.L. declares that the above mentioned products meet the provision of the Council
Directive 93/42/EEC for Medical Devices and Directive 93/42/EEC as transposed in the national laws of
the Member States.
COMPANY REPRESENTATIVE: Mr. Jorge Villardino
TITLE: Director
DATE: 12/01/2016
BIOGENESIS Offices
Plaza Independencia 831, office 607
ZIP 11.100 | Montevideo – Uruguay
T +598 2904 78 68
[email protected]
www.biogenesis.com.uy
SIGNATURE: ______________________