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Notification

Found : 9
  Body (History):

INSTYTUT TECHNIK I TECHNOLOGII DZIEWIARSKICH (TRICOTEXTIL)
ul. Piotrkowska 270
90-361 Lodz
Country : Poland

Phone : +48 (42) 684 02 81
Fax : +48 (42) 683 58 91

Email : sekretariat@tricotextil.lodz.pl
Website : www.tricotextil.lodz.pl

Notified Body number : 1435

Version(s): 1 2 3 4 5 6

Last update : 02/08/2006
 

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Some information about the accreditation details are available in the PDF
Legislation
93/42/EEC Medical devices     (History)
Last update : 02/08/2006                 Version(s): 1 2

Products Procedures Articles/Annexes Limitations
active therapeutic devices intended to administer or exchange energy - Class IIa
Full quality assurance system
EC verification
Production quality assurance
Product quality assurance
Annex II
Annex IV
Annex V
Annex VI
 
devices intended to be used for disinfection - Class IIa
Full quality assurance system
EC verification
Production quality assurance
Product quality assurance
Annex II
Annex IV
Annex V
Annex VI
 
invasive medical devices intended to administer and/or remove medicines, body liquids or other substances to or from the body - Class IIa, made of plastic
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
 
invasive, non-active implants - Class IIb, III, made of textiles
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
 
medical devices containing a medicinal product - Class III
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Annex II
Annex III
Annex IV
Annex V
 
medical devices used for contraception - Class IIb
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-invasive medical devices intended for channelling or storing blood or body liquids - Class IIa and IIb, made of plastic
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
 
primary wound dressing which come into contact with injured skin - Class I-sterile, IIa and IIb
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
 
surgical threads - Class IIb and III, natural and synthetic
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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