Notification of a Body in the framework of a technical

harmonization directive
From : Czech Office for Standards, To : European Commission
Metrology and Testing Enterprise Directorate-General
Gorazdova 24 P.O.BOX 49 -
128 01 Praha 2 B 1049 Brussels
Czech Republic
Other Member States

Reference : Directive : 93/42/EEC Medical devices

Body name, address, telephone, fax, email, website :

INSTITUT PRO TESTOVANI A CERTIFIKACI a.s.

T. Bati 299
764 21 ZLIN - LOUKY
Czech Republic
Phone : +420-577 104 776
Fax : +420-577 104 855
Email : certif@itczlin.cz
Website : www.itczlin.cz

Type of body : NB 1023

Created : unknown | Last update : 04/01/2007

Period of validity of the notification :

Valid until : Unlimited
Basis of competence assessment :
The body has :
- the required technical competence in relation to the product(s) under this directive
- sufficient competence in relation to the procedure(s)/attestation of conformity selected for these product(s)
Unknown
Competence assessment performed by :

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Tasks performed by the Body :
Created : unknown | Last update :

Product family, product /Intended use/Product range Procedure/Modules Annexes or articles of the
directives
All medical devices Full quality assurance system Annex II
EC Type-examination Annex III
EC verification Annex IV
Production quality assurance Annex V
Product quality assurance Annex VI

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