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Notification

Found : 4
  Body (History):

EUROCAT - INSTITUTE FOR CERTIFICATION AND TESTING GMBH
Quarat Center, Wittichstrasse 2
64295 DARMSTADT
Country : Germany

Phone : +49:6151:500 35 0
Fax : +49:6151:500 35 50

Email : info@eurocat.de
Website : http://www.eurocat.de

Notified Body number : 0535

Version(s): 1 2 3 4 5 6 7 8 9 10

Last update : 16/11/2010
 

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Some information about the accreditation details are available in the PDF
Legislation
90/385/EEC Active implantable medical devices    
Last update : 22/04/2010                 Version(s): 1 2

Products Procedures Articles/Annexes Limitations
*AIMD 0100 - General active implantable medical devices
 
   - *AIMD 0101 - Active implantable medical devices for stimulation / inhibition
EC declaration of conformity (complete quality assurance system)
EC declaration of conformity to type (assurance of production quality)
EC type-examination
EC verification
Annex 2
Annex 5
Annex 3
Annex 4
 
   - *AIMD 0102 - Active implantable medical devices delivering drugs or other substances
EC declaration of conformity (complete quality assurance system)
EC declaration of conformity to type (assurance of production quality)
EC type-examination
EC verification
Annex 2
Annex 5
Annex 3
Annex 4
 
   - *AIMD 0103 - Active implantable medical devices substituting or replacing organ functions
EC declaration of conformity (complete quality assurance system)
EC declaration of conformity to type (assurance of production quality)
EC type-examination
EC verification
Annex 2
Annex 5
Annex 3
Annex 4
 
 
Horizontal technical competence Limitations
*MDS 7004 - Medical devices referencing the Directive 2006/42/EC on machinery  
*MDS 7006 - Medical devices in sterile condition  
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