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Notification

Found : 28
  Body (History):

MDC MEDICAL DEVICE CERTIFICATION GMBH
Kriegerstrasse 6
70191 STUTTGART
Country : Germany

Phone : +49:711:253597 0
Fax : +49:711:253597 10

Email : mdc@mdc-ce.de
Website : http://www.mdc-ce.de

Notified Body number : 0483

Version(s): 1 2 3 4 5 6 7 8

Last update : 11/09/2008
 

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Some information about the accreditation details are available in the PDF
Legislation
93/42/EEC Medical devices     (History)
Last update : 11/09/2008                 Version(s): 1 2 3 4

Products Procedures Articles/Annexes Limitations
Active medical devices, except
 
   - devices for extracorporal circulation, haemopheresis
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - devices for hyperbaric therapy
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - devices for inhalation anaesthesia
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - external cardiac pacemakers and defibrillators
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - hyperthermy devices
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - litholripter
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
Active medical devices
 
   - dental equipment
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - devices for imaging
 
   -
      - with ionizing radiation
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   -
      - with non-ionizing radiation
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - devices to monitor and determine vital signs
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - disinfection and sterilization equipment
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - imaging equipment
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - infusion devices
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - medical supply units
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - ophtalmological devices
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - patient positioning and transport equipment
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - prostheses and rehabilitation devices
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - radiotherapy devices
 
   -
      - with ionizing radiation and with non-ionizing radiation
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - software
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - stimulators
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - surgical devices and aids
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - ventilators and oxygen therapy apparatus
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
Non-active medical devices
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
non-active medical devices with already existing EC type examination certificate
EC type-examination Annex III  
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