European Commission - Enterprise and Industry

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Notification

Found : 1
 
  Body (History):

Gyógyszerészeti és Egészségügyi Minőség- és Szervezetfejlesztési Intézet Eszközminősítő és Kórháztechnikai Igazgatóság (National Institute for Quality- and Organizational Development in Healthcare and Medicines Directorate of Device Testing and Engineering)
Diós árok 3
H-1125 Budapest
Country : Hungary

Phone : +36 1 356-1522
Fax : +36 1 375-7253

Email : cert@emki.hu
Website : www.emki.hu

Notified Body number : 1011

Version(s): 1 2 3 4

Last update : 25/10/2011
 

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Some information about the accreditation details are available in the PDF
Legislation
90/385/EEC Active implantable medical devices     (History)
Last update : Unknown (Notifications pre-dating 2006 are not available in these lists)                 Version(s): 1 2

Products Procedures Articles/Annexes Limitations
Implantable heart pacemakers
EC declaration of conformity (complete quality assurance system)
EC declaration of conformity to type (assurance of production quality)
EC type-examination
EC verification
Annex 2
Annex 5
Annex 3
Annex 4