European Commission - Growth

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Notification

Found : 2
 
  Body :

CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft.
Erdő u.101.
Budakeszi
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

Version(s): 1 2

Last approval date : 20/02/2020
 

Return to legislation list

Some information about the accreditation details are available in the PDF
Legislation
90/385/EEC Active implantable medical devices    
Last approval date : 08/09/2020                 Version(s): 1 2 3 4 5 6

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 regarding Annex 2 or 5
*MDS 7004 - Medical devices referencing the Directive 2006/42/EC on machinery regarding Annex 2 or 5
*MDS 7006 - Medical devices in sterile condition regarding Annex 2 or 5 Including aseptic processing, ethylene oxide gas sterilisation (EOG), radiation sterilization (gamma,x-ray, electron beam), moist heat sterilization
*MDS 7009 - Medical devices utilising biological active coatings and/or materials or being wholly or mainly absorbd regarding Annex 2 or 5
*MDS 7010 - Medical devices incorporating software / utilising software / controlled by software regarding Annex 2 or 5