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Notification

Found : 14
  Body (History):

CERTIQUALITY S.R.L. - ISTITUTO DI CERTIFICAZIONE DELLA QUALITA'
Via G. Giardino, 4
20123 - MILANO
Country : Italy

Phone : +39 02 8069171
Fax : +39 02 86465295

Email : certiquality@certiquality.it
Website : www.certiquality.it

Notified Body number : 0546

Version(s): 1 2 3 4

Last update : 17/12/2008
 

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Some information about the accreditation details are available in the PDF
Legislation
93/42/EEC Medical devices     (History)
Last update : 07/05/2007                 Version(s): 1 2

Products Procedures Articles/Annexes Limitations
All Class I sterile devices
Production quality assurance
Product quality assurance
Annex V
Annex VI
 
Bendages, dressings, plasters, etc.
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
Catheters and accessories
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
Contraceptive products
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
Dental products and materials and accessories, including powered accessories
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
Medical and measuring equipment with independent power supply or non-powered
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
Ophtalmic products
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
Orthopaedic and rehabilitation products and materials and accessories, including powered accessories
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
Products and accessories for surgical use
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
Products for anaesthesia, reanimation and respiration
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
Products for disinfection of medical equipment and for the treatment of contact lenses
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
Products for endoscopy and laparoscopy
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
Products for extracorporeal circulation and accessories, including active accessories
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
non-active devices specifically intended for recording of X-ray diagnostic images
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
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