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Notification

Found : 4
  Body (History):

MEDCERT ZERTIFIZIERUNGS- UND PRÜFUNGSGESELLSCHAFT FÜR DIE MEDIZIN GMBH
Pilatuspool 2
20355 HAMBURG
Country : Germany

Phone : +49:40:22633250
Fax : +49:40:226332515

Email : info@medcert.de
Website : http://www.medcert.de

Notified Body number : 0482

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

Last update : 22/04/2010
 

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Some information about the accreditation details are available in the PDF
Legislation
93/42/EEC Medical devices     (History)
Last update : 12/09/2008                 Version(s): 1 2 3

Products Procedures Articles/Annexes Limitations
Active medical devices, except
 
   - x-ray diagnostic devices for CT and angiographie; MR-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
 
Medical devices covered by directive 2003/32/EC
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
Non-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
 
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