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Notification

Found : 22
  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 : 17/03/2008
 

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Some information about the accreditation details are available in the PDF
Legislation
93/42/EEC Medical devices     (History)
Last update : 17/03/2008                 Version(s): 1 2

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