0481 - NOTIFIED BODY (UNDER DIRECTIVE 93/42/EEC Medical devices)

Name and address of the notified bodie
Responsible for the following products
Responsable for the following procedures/modules
Annexes/articles of the directives

ECM -
ZERTIFIZIERUNGSGESELLSCHAFT
FÜR MEDIZINPRODUKTE UN EUROPA MBH
eifelstrasse, 1C
D - 52068 Aachen

T : 00 49 241 501034
F : 00 49 241 201038
URL :
Email :

Non -active medical products :

  • Disposable medical products :
  • infusion/transfusion sets
  • catheters/catheter sets
  • drainage devices
  • tubing for extracorporeal circulation

 

  • OP products
  • bandages and dressings

Full quality assurance
Type-examiniation
EC verification
Production quality assurance
Product quality assurance

 

Annex II
Annex III
Annex IV
Annex V
Annex VI

 

 

  • soft tissue implants
  • disinfection means
  • orthopaedic implants
  • contact lenses
  • contact lens care products

Full quality assurance
Production quality assurance
Product quality assurance

Annex II
Annex V
Annex VI


site - http://www.hosmat.fr - dernière mise à jour : 10 janvier 2000