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Notification

Found : 18
  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     (History)
Last update : 27/09/2007                 Version(s): 1 2 3 4 5

Products Procedures Articles/Annexes Limitations
Non-active medical devices
 
   - Devices for wound care
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - Implants
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - OP products
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
 
   - bandages and dressings
EC type-examination
EC verification
Annex III
Annex IV
 
   - dental materials
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - disinfection means
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - disposable medical devices
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - epidural catheters
EC type-examination
EC verification
Annex III
Annex IV
 
   - implantable catheters
EC type-examination
EC verification
Annex III
Annex IV
 
   - infusion / transfusion sets
 
   -
      - catheters / catheter sets
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
 
   -
      - drainage devices
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
 
   -
      - tubing for extracorporeal circulation
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
 
   - medical devices with special constituents/raw materials with conformity assessment
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - non-implantable medical devices
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - ophtalmological products
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - spinal catheters
EC type-examination
EC verification
Annex III
Annex IV
 
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