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Notification

Found : 9
  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
 

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Some information about the accreditation details are available in the PDF
Legislation
98/79/EC In vitro diagnostic medical devices     (History)
Last update : 29/03/2010                 Version(s): 1 2 3 4

Products Procedures Articles/Annexes Limitations
*IVD 0300 - Reagents, reagent products and devices for self-diagnosis, including related calibrators and control materials, for determining, detection, quantification, diagnosing, evaluating
 
   - *IVD 0309 - Device for self-diagnosis: device for the measurement of blood sugar
Full quality assurance system
Production quality assurance
Annex IV
Annex VII
 
*IVD 0400 - Devices for self-testing
 
   - *IVD 0401 - Clinical chemistry
Full quality assurance system
Production quality assurance
Annex IV
Annex VII
 
   - *IVD 0402 - Haematology
Full quality assurance system
Production quality assurance
Annex IV
Annex VII
 
   - *IVD 0403 - Immunology
Full quality assurance system
Production quality assurance
Annex IV
Annex VII
 
   - *IVD 0404 - Molecular biology
Full quality assurance system
Production quality assurance
Annex IV
Annex VII
 
   - *IVD 0405 - Pregnancy and ovulation
Full quality assurance system
Production quality assurance
Annex IV
Annex VII
 
   - *IVD 0406 - Specimen receptacles
Full quality assurance system
Production quality assurance
Annex IV
Annex VII
 
 
Horizontal technical competence Limitations
*MDS 7206 - IVDs in sterile condition  
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