European Commission - Enterprise and Industry

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Notification

Found : 8
 
  Body (History):

EUROCAT - INSTITUTE FOR CERTIFICATION AND TESTING GMBH
Quarat Center, Wittichstrasse 2
64295 DARMSTADT
Country : Germany

Phone : +49:6151:500 35 0
Fax : +49:6151:500 35 50

Email : kexel@eurocat.de
Website : http://www.eurocat.de

Notified Body number : 0535

Version(s): 1 2 3 4 5 6 7 8 9 10

Last update : 08/09/2008
 

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Some information about the accreditation details are available in the PDF
Legislation
93/42/EEC Medical devices     (History)
Last update : 08/09/2008                 Version(s): 1 2 3

Products Procedures Articles/Annexes Limitations
Active medical devices
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
 
Non-active medical devices
 
   - Devices for wound care
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - Implants
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - disposable medical devices
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - instruments and equipment for dentistry
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - medical devices with special constituents/raw materials
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - non-implantable medical devices
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI