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Notification

Found : 8
  Body :

BSI Group Deutschland GmbH
Hanauer Landstrasse 115
60314 Frankfurt am Main
Country : Germany

Phone : +49 (69) 22 22 89 200
Fax : +49 (69) 22 22 89 300

Email : md-cert.de@bsigroup.com
Website : www.bsigroup.de

Notified Body number : 0535

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

Last update : 09/10/2012
 

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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 4

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
 
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