European Commission - Enterprise and Industry

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Notification

Found : 2
 
  Body :

TEXTILNÍ ZKUŠEBNÍ ÚSTAV s.p.
Václavská 6
658 41 BRNO
Country : Czech Republic

Phone : +420::543426711
Fax : +420::543243590

Email : malcik@tzu.cz
Website : www.tzu.cz

Notified Body number : 1021

Version(s): 1 2 3

Last update : 23/10/2008
 

Return to legislation list

Some information about the accreditation details are available in the PDF
Legislation
93/42/EEC Medical devices     (History)
Last update : Unknown (Notifications pre-dating 2006 are not available in these lists)                 Version(s): 1 2 3 4 5

Products Procedures Articles/Annexes Limitations
Disposable medical devices (only manufactured from textile or composed devices based on textile or manufactured from plastic materials with just the same usage)
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 implantable medical devices (only from textile or composed devices based on textile)
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