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Notification

Found : 2
  Body (History):

MEDCERT ZERTIFIZIERUNGS- UND PRÜFUNGSGESELLSCHAFT FÜR DIE MEDIZIN GMBH
Pilatuspool 2
20355 HAMBURG
Country : Germany

Phone : +49:40:22633250
Fax : +49:40:226332515

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

Notified Body number : 0482

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

Last update : 06/05/2010
 

Return to legislation list

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 3 4

Products Procedures Articles/Annexes Limitations
*AIMD 0100 - General active implantable medical devices
 
   - *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)
Annex 2
Annex 5
refill kits for implantable pumps 
 
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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