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Notification

Found : 2
  Body :

CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft.
Gyár u. 2.
Budaörs
Country : Hungary

Phone : 00-36-23-880-830
Fax : 00-36-23-880-831

Email : info@cecertiso.hu
Website : www.cecertiso.hu

Notified Body number : 2409

Last update : 17/09/2012
 

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 : 25/09/2012
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)
Annex 2
Annex 5
 
 
Horizontal technical competence Limitations
*MDS 7001 - Medical devices incorporating medicinal substances according to Directive 2001/83/EC  
*MDS 7004 - Medical devices referencing the Directive 2006/42/EC on machinery  
*MDS 7006 - Medical devices in sterile condition  
*MDS 7009 - Medical devices utilising biological active coatings and/or materials or being wholly or mainly absorbd  
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