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Notification

Found : 2
  Body (History):

Oficiul Tehnic de Dispozitive Medicale-OTDM CERTIFICARE
B-dul Nicolae Titulescu nr. 58, sector 1, cod postal 011144
Bucuresti
Country : Romania

Phone : +4021-222 86 52
Fax : +4021-222 86 83

Email : secretariat@otdm.ro
Website : -

Notified Body number : 1868

Version(s): 1 2 3

Last update : 11/04/2007
 

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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
Active medical devices and their accessories
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 medical devices
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
 
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