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Found : 7
  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 : ksc@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 28

Last update : 04/11/2009
 

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Some information about the accreditation details are available in the PDF
Legislation
93/42/EEC Medical devices     (History)
Last update : 09/09/2008                 Version(s): 1 2 3

Products Procedures Articles/Annexes Limitations
Active medical devices, except
 
   - hyperbaric therapy chambers
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
 
   - hyperthermy devices
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
 
   - medical supply units
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
 
   - software
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
 
Medical devices covered by directive 2003/32/EC
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
Non-active medical devices
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
 
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