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Notification

Found : 5
  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 : Unknown (Notifications pre-dating 2006 are not available in these lists)                 Version(s): 1 2 3 4

Products Procedures Articles/Annexes Limitations
All active medical devices (except for devices for hyperbaric therapy)
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, except Class III devices
 
   - bandages and dressings
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - dental devices
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - reusable non-active medical instruments
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
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