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Found : 9
  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 : 29/03/2010
 

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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

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
EC declaration of conformity
Full quality assurance system
Production quality assurance
Annex III
Annex IV
Annex VII
 
   - *IVD 0402 - Haematology
EC declaration of conformity
Full quality assurance system
Production quality assurance
Annex III
Annex IV
Annex VII
 
   - *IVD 0403 - Immunology
EC declaration of conformity
Full quality assurance system
Production quality assurance
Annex III
Annex IV
Annex VII
 
   - *IVD 0404 - Molecular biology
EC declaration of conformity
Full quality assurance system
Production quality assurance
Annex III
Annex IV
Annex VII
 
   - *IVD 0405 - Pregnancy and ovulation
EC declaration of conformity
Full quality assurance system
Production quality assurance
Annex III
Annex IV
Annex VII
 
   - *IVD 0406 - Specimen receptacles
EC declaration of conformity
Full quality assurance system
Production quality assurance
Annex III
Annex IV
Annex VII
 
 
Horizontal technical competence Limitations
*MDS 7206 - IVDs in sterile condition  
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