European Commission - Enterprise and Industry

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Notification

Found : 2
 
  Body (History):

EUROCAT - INSTITUTE FOR CERTIFICATION AND TESTING GMBH
Quarat Center, Wittichstrasse 2
64295 DARMSTADT
Country : Germany

Phone : +49:6151:500 35 0
Fax : +49:6151:500 35 50

Email : kexel@eurocat.de
Website : http://www.eurocat.de

Notified Body number : 0535

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

Last update : 08/09/2008
 

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 : 09/07/2008                 Version(s): 1 2

Products Procedures Articles/Annexes Limitations
Devices for self-testing
Full quality assurance system
Production quality assurance
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
Production quality assurance
Annex IV
Annex VII