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  Body :

EVPU a.s.
Trencianska 19
018 51 NOVA DUBNICA
Country : Slovakia

Phone : +421 (42) 4403600
Fax : +421 (42) 4403502

Email : hudak@evpu.sk, vrankova@evpu.sk
Website : www.evpu.sk

Notified Body number : 1293

Version(s): 1 2 3 4 5 6 7 8 9 10 11 12

Last update : 09/08/2011
 

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Some information about the accreditation details are available in the PDF
Legislation
90/385/EEC Active implantable medical devices     (History)
Last update : 26/05/2010                 Version(s): 1 2 3

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
 
 
Horizontal technical competence Limitations
*MDS 7001 - Medical devices incorporating medicinal substances according to Directive 2001/83/EC  
*MDS 7003 - Medical devices incorporating derivates of human blood according to Directive 2000/70/EC, amended by Directive 2001/104/EC  
*MDS 7004 - Medical devices referencing the Directive 2006/42/EC on machinery  
*MDS 7005 - Medical devices referencing the Directive 89/686/EEC on PPE (personal protective equipment)  
*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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