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Notification

Found : 2
  Body (History):

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 : 21/04/2009
 

Return to legislation list

Some information about the accreditation details are available in the PDF
Legislation
98/79/EC In vitro diagnostic medical devices     (History)
Last update : 10/07/2008                 Version(s): 1 2

Products Procedures Articles/Annexes Limitations
Devices for self-testing
EC declaration of conformity
Full quality assurance system
Production quality assurance
Annex III
Annex IV
Annex VII
 
The following device for self-diagnosis, including its related calibrators and control materials: device for the measurement of blood sugar
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Annex IV
Annex V
Annex VI
Annex VII
 
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