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Notification

Found : 15
  Body :

INTERTEK SEMKO AB
PO Box 1103
164 22 KISTA
Country : Sweden

Phone : +46/8.750.00.00
Fax : +46/8.750.60.30

Email : bertil.warme@intertek.com
Website : www.sweden.intertek-etlsemko.com

Notified Body number : 0413

Version(s): 1 2 3 4 5

Last update : 31/01/2011
 

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Some information about the accreditation details are available in the PDF
Legislation
93/42/EEC 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
Active devices intended for diagnosis
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
Active therapeutic devices
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
Class I devices with a measuring function
EC verification Annex IV  
Devices for the administration to or removal from the patient's body of medicines, body fluids or other substances
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
Devices with a measuring function
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
Disposables
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
Electrical devices intended for diagnosis
EC type-examination
EC verification
Annex III
Annex IV
 
Electrical devices intended to administer and/or remove medicines or products, body liquids or other substances to or from the body
EC type-examination
EC verification
Annex III
Annex IV
 
Electrical therapeutic devices
EC type-examination
EC verification
Annex III
Annex IV
 
Passive implants
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
Re-usable devices
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
Sterile devices
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
Wound dressings
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
dental devices
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
functional implants
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
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