European Commission - Enterprise and Industry

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Notification

Found : 2
 
  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
 

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 3 4

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