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Notification

Found : 23
  Body :

ECM-ZERTIFIZIERUNGSGESELLSCHAFT FÜR MEDIZINPRODUKTE IN EUROPA MBH
Bismarckstraße 106
52066 AACHEN
Country : Germany

Phone : +49:241:5010 34
Fax : +49:241:5010 38

Email : ecm@medi-online.com
Website : http://www.medi-online.com

Notified Body number : 0481

Version(s): 1 2 3 4 5 6

Last update : 22/04/2010
 

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Some information about the accreditation details are available in the PDF
Legislation
93/42/EEC Medical devices    
Last update : 22/04/2010                 Version(s): 1 2 3 4 5

Products Procedures Articles/Annexes Limitations
*MD 0100 - General non-active, non-implantable medical devices
 
   - *MD 0101 - Non-active devices for anaesthesia, emergency and intensive care
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - *MD 0102 - Non-active devices for injection, infusion, transfusion and dialysis
Full quality assurance system
EC type-examination
Production quality assurance
Product quality assurance
Annex II
Annex III
Annex V
Annex VI
Annex III: Only infusion sets, transfusion sets, catheters, tubing systems for extra-corporal circulation 
   - *MD 0103 - Non-active orthopaedic and rehabilitation devices
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - *MD 0104 - Non-active medical devices with measuring function
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - *MD 0105 - Non-active ophthalmologic devices
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - *MD 0106 - Non-active instruments
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - *MD 0107 - Contraceptive medical devices
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - *MD 0108 - Non-active medical devices for disinfecting, cleaning, rinsing
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - *MD 0109 - Non-active devices for in vitro fertilisation (IVF) and assisted reproductive technologies (ART)
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
*MD 0200 - Non-active implants
 
   - *MD 0201 - Non-active cardiovascular implants
Full quality assurance system
EC type-examination
Production quality assurance
Product quality assurance
Annex II
Annex III
Annex V
Annex VI
Only stents, implantable catheters, vascular grafts, occlusion systems 
   - *MD 0202 - Non-active orthopaedic implants
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - *MD 0203 - Non-active functional implants
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
Only introcular lenses 
   - *MD 0204 - Non-active soft tissue implants
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
*MD 0300 - Devices for wound care
 
   - *MD 0301 - Bandages and wound dressings
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - *MD 0302 - Suture material and clamps
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - *MD 0303 - Other medical devices for wound care
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
*MD 0400 - Non-active dental devices and accessories
 
   - *MD 0401 - Non-active dental equipment and instruments
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - *MD 0402 - Dental materials
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - *MD 0403 - Dental implants
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
 
Horizontal technical competence Limitations
*MDS 7001 - Medical devices incorporating medicinal substances, according to Directive 2001/83/EC  
*MDS 7002 - Medical devices utilising tissues of animal origin, including Regulation 722/2012 (Directive 2003/32/EC up to 28.08.2013) Only devices with existing TSE Certificate of Suitability for the starting materials issued by the European Directorate for the Qualits of Medicines (EDQM)
*MDS 7006 - Medical devices in sterile condition  
*MDS 7009 - Medical devices utilising biological active coatings and/or materials or being wholly or mainly absorbed  
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