European Commission - Enterprise and Industry

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Notification

Found : 13
 
  Body :

SGS Société Générale de Surveillance AG
Technoparkstrasse 1
CH-8005 Zürich
Country : Switzerland

Phone : +41:44:445 16 80
Fax : +41:44:445 16 88

Email : info.zh@sgs.com
Website : ch.sgs.com

Notified Body number : 1251

Version(s): 1 2 3

Last update : 17/12/2009
 

Return to legislation list

Some information about the accreditation details are available in the PDF
Legislation
93/42/EEC Medical devices     (History)
Last update : 17/12/2009                 Version(s): 1 2 3

Products Procedures Articles/Annexes Limitations
*MD 0100 - General non-active, non-implantable medical devices
 
   - *MD 0103 - Non-active orthopaedic and rehabilitation devices
Production quality assurance Annex V  
   - *MD 0106 - Non-active instruments
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
*MD 0300 - Devices for wound care
 
   - *MD 0301 - Bandages and wound dressings
Production quality assurance Annex V  
*MD 0400 - Non-active dental devices and accessories
 
   - *MD 0401 - Non-active dental equipment and instruments
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
*MD 1100 - General active medical devices
 
   - *MD 1106 - Active dental devices
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
   - *MD 1107 - Active devices for disinfection and sterilisation
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
   - *MD 1111 - Software
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
*MD 1200 - Devices for imaging
 
   - *MD 1202 - Imaging devices utilising non-ionizing radiation
Full quality assurance system
Production quality assurance
Annex II
Annex V