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Notification

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  Body (History):

TÜV RHEINLAND PRODUCT SAFETY GMBH
Am Grauen Stein
51105 Köln
Country : Germany

Phone : +49:221:806 2048
Fax : +49:221:806 3935

Email : medical-products@de.tuv.com
Website : http://www.tuv.com

Notified Body number : 0197

Version(s): 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27

Last update : 07/12/2007
 

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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 :
Products Procedures Articles/Annexes Limitations
Devices for self-testing
EC declaration of conformity
Full quality assurance system
Production quality assurance
Annex III
Annex IV
Annex VII
 
Products referred in Annex II, list A
Full quality assurance system
EC type-examination
Production quality assurance
Annex IV
Annex V
Annex VII
 
Products referred in Annex II, list B
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Annex IV
Annex V
Annex VI
Annex VII
 
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