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Notification

Found : 15
  Body (History):

POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. (PCBC)
ul. Klobucka 23A
02-699 Warszawa
Country : Poland

Phone : +48 (22) 464 52 01
Fax : +48 (22) 647 12 22

Email : polskie.centrum@pcbc.gov.pl
Website : www.pcbc.gov.pl

Notified Body number : 1434

Version(s): 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17

Last update : 14/02/2007
 

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Some information about the accreditation details are available in the PDF
Legislation
93/42/EEC Medical devices     (History)
Last update : 11/09/2006                 Version(s): 1 2

Products Procedures Articles/Annexes Limitations
Catheters, drains and probes
Full quality assurance system
EC type-examination
Production quality assurance
Product quality assurance
Annex II
Annex III
Annex V
Annex VI
 
Gloves for medical use
Full quality assurance system
EC type-examination
Production quality assurance
Product quality assurance
Annex II
Annex III
Annex V
Annex VI
 
Medical gas pipeline systems
Full quality assurance system Annex II  
Probes and catheters for urology, gastroenterology, respiratory tracts, surgical aspiration and oxygen therapy
Full quality assurance system
EC type-examination
Production quality assurance
Product quality assurance
Annex II
Annex III
Annex V
Annex VI
 
Syringes
Full quality assurance system
EC type-examination
Production quality assurance
Product quality assurance
Annex II
Annex III
Annex V
Annex VI
 
active prosthesis and rehabilitation 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
 
condoms and pessaries
Full quality assurance system
EC type-examination
Production quality assurance
Product quality assurance
Annex II
Annex III
Annex V
Annex VI
 
dental rotary instruments
Full quality assurance system
EC type-examination
Production quality assurance
Product quality assurance
Annex II
Annex III
Annex V
Annex VI
 
devices designed to image the function of the organs
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
 
disinfectants and sterilizers for 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
 
electromedical apparatus for diagnosis and therapy
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
 
equipment for non-ionizing (laser, UV, temperature) and ionizing radiation therapy; software for therapy planning
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
 
implants exept orthopaedic implants and artificial heart valves
Full quality assurance system
EC type-examination
Production quality assurance
Product quality assurance
Annex II
Annex III
Annex V
Annex VI
 
multiple-use surgical instruments in Class IIa and above
Full quality assurance system
EC type-examination
Production quality assurance
Product quality assurance
Annex II
Annex III
Annex V
Annex VI
 
sterile medical devices except ophtalmic devices (Class IIa and above)
Full quality assurance system
EC type-examination
Production quality assurance
Product quality assurance
Annex II
Annex III
Annex V
Annex VI
 
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