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Notification

Found : 13
  Body :

DEKRA Certification GmbH
Handwerkstra├če 15
70565 STUTTGART
Country : Germany

Phone : +49 7 11 / 78 61 25 66
Fax : +49 7 11 / 78 61 26 15

Email : info@dekra-certification.com
Website : http://www.dekra.de

Notified Body number : 0124

Version(s): 1 2 3 4 5 6 7 8 9 10 11 12 13 14

Last update : 29/09/2010
 

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Some information about the accreditation details are available in the PDF
Legislation
93/42/EEC Medical devices     (History)
Last update : 09/07/2008                 Version(s): 1 2 3 4 5 6 7 8

Products Procedures Articles/Annexes Limitations
Active medical devices
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
All active medical devices except devices for disinfection and sterilisation
EC type-examination
EC verification
Annex III
Annex IV
 
Alle active medical devices except devices for extracorporeal circulation, infusion, haemopheresis
EC type-examination
EC verification
Annex III
Annex IV
 
Alle active medical devices except devices for oxygen therapy an inhalation anaesthesia
EC type-examination
EC verification
Annex III
Annex IV
 
Alle active medical devices except devices for radiotherapy utilizing ionizing radiation
EC type-examination
EC verification
Annex III
Annex IV
 
Alle active medical devices except ophthalmologic devices
EC type-examination
EC verification
Annex III
Annex IV
 
Alle active medical devices except rehabilitation devices and active prostheses
EC type-examination
EC verification
Annex III
Annex IV
 
Alle active medical devices except respiratory devices
EC type-examination
EC verification
Annex III
Annex IV
 
Devices with already existing EC type examination certificate
EC type-examination Annex III  
Male condoms
EC type-examination
EC verification
Annex III
Annex IV
 
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
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
non-active medical devices with already existing EC type examination certificate
EC type-examination Annex III  
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