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Notification

Found : 5
  Body :

VYSKUMNY USTAV ZVARACSKY - PRIEMYSELNY INSTITUT SLOVENSKEJ REPUBLIKY
Racianska 71
832 59 BRATISLAVA
Country : Slovakia

Phone : +421:2:49246804
Fax : +421:2:49246302

Email : sktc@vuz.sk
Website : www.vuz.sk

Notified Body number : 1297

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

Last update : 04/06/2013
 

Return to legislation list

Some information about the accreditation details are available in the PDF
Legislation
93/42/EEC Medical devices     (History)
Last update : 29/03/2010                 Version(s): 1 2 3

Products Procedures Articles/Annexes Limitations
*MD 0100 - General non-active, non-implantable medical devices
 
   - *MD 0104 - Non-active medical devices with measuring function
Full quality assurance system
EC verification
Production quality assurance
Product quality assurance
Annex II
Annex IV
Annex V
Annex VI
 
   - *MD 0106 - Non-active instruments
Full quality assurance system
EC verification
Production quality assurance
Product quality assurance
Annex II
Annex IV
Annex V
Annex VI
 
*MD 1100 - General active medical devices
 
   - *MD 1102 - Respiratory devices, devices including hyperbaric chambers for oxygen therapy, inhalation anaesthesia
Full quality assurance system
EC verification
Production quality assurance
Product quality assurance
Annex II
Annex IV
Annex V
Annex VI
 
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