European Commission - Enterprise and Industry

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Notification

Found : 2
 
  Body (History):

SCHWEIZERISCHE VEREINIGUNG FÜR QUALITÄTS- UND MANAGEMENTSYSTEME
Bernstrasse 103
3052 ZOLLIKOFEN
Country : Switzerland

Phone : +41:31:910 35 35
Fax : +41:31:910 35 45

Email : headoffice@sqs.ch
Website : www.sqs.ch

Notified Body number : 1250

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

Last update : 19/04/2010
 

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 : 19/04/2010                 Version(s): 1 2

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