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Notification

Found : 11
  Body (History):

STROJIRENSKY ZKUSEBNI USTAV s.p.
Hudcova 56B
621 00 BRNO
Country : Czech Republic

Phone : +420::541120111
Fax : +420::541211225

Email : szu@szutest.cz
Website : www.szutest.cz

Notified Body number : 1015

Version(s): 1 2 3 4 5 6 7 8 9 10

Last update : 12/09/2008
 

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Some information about the accreditation details are available in the PDF
Legislation
93/42/EEC Medical devices     (History)
Last update : 17/10/2006                 Version(s): 1 2

Products Procedures Articles/Annexes Limitations
All medical devices
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
Anaesthetic and respiratory equipment
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
 
Disposable syringes and needles
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
 
Electromechanical 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 dentistry and stomatology
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
 
Hospital equipment (equipment for sterilization, disinfection, transport of patients and also transportable incubators)
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 for actinopraxis (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
 
Non-active implantable medical devices (except devices manufactured from plastic and ceramic materials)
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
 
Ophthalmic and optic medical devices (only active electrical 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
 
Re-usable 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
 
Technical aids for handicapped people - wheelchairs and lifting 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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