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Notification

Found : 18
  Body (History):

ICIM - ISTITUTO DI CERTIFICAZIONE INDUSTRIALE PER LA MECCANICA S.P.A.
Piazza A. Diaz, 2
20123 - MILANO
Country : Italy

Phone : +39 02 725341
Fax : +39 02 72002098

Email : icimorg@tin.it
Website : www.icim.it

Notified Body number : 0425

Version(s): 1 2 3 4 5 6 7 8 9 10 11 12

Last update : 11/07/2008
 

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Some information about the accreditation details are available in the PDF
Legislation
93/42/EEC Medical devices     (History)
Last update :
Products Procedures Articles/Annexes Limitations
Blood pressure measurement devices
 
   - capnometers
EC type-examination
EC verification
Annex III
Annex IV
 
   - fever thermometers (active)
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
 
Catheters and accessories
EC type-examination
EC verification
Annex III
Annex IV
 
Devices for anaesthesia and ventilation
 
   - dental equipment (units, treatment chairs, etc.)
EC type-examination
EC verification
Annex III
Annex IV
 
Devices, materials and apparatus for dental treatment
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
Dressings
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
Medical gas pipeline systems
 
   - disinfection and sterilization equipment
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
 
Non active devices specifically intended for recording of X-ray diagnostic images. (Annex IX, 4.4. Rule 16)
 
   - capnometers
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
Non-active class I devices with a measuring function
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
Operating theatre equipment
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
Products and accessories for surgical use, such as suture needles, syringes, surgical gloves
 
   - Pulse oxymeters
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
 
   - contact lenses
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
 
Single Usage Device (?)
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
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