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Notification

Found : 19
  Body :

INTERTEK TESTING & CERTIFICATION LTD
Intertek House, Cleeve Road
Leatherhead, Surrey KT22 7SB
Country : United Kingdom

Phone : +44 (0) 1372 370900
Fax : +44 (0) 1372 370999

Email : talban.sohi@intertek.com
Website : www.intertek.com

Notified Body number : 0359

Version(s): 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22

Last update : 11/07/2013
 

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Some information about the accreditation details are available in the PDF
Legislation
93/42/EEC Medical devices    
Last update : 09/10/2013                 Version(s): 1 2 3 4

Products Procedures Articles/Annexes Limitations
*MD 1100 - General active medical devices
 
   - *MD 1101 - Devices for extra-corporal circulation, infusion and haemopheresis
EC verification Annex IV Excluding Extracorporeal Blood Treatment Equipment 
   - *MD 1103 - Devices for stimulation or inhibition
EC verification Annex IV Excluding Defibrillators 
   - *MD 1104 - Active surgical devices
EC verification Annex IV Excluding Electrosurgical Equipment 
   - *MD 1105 - Active ophthalmologic devices
EC verification Annex IV  
   - *MD 1106 - Active dental devices
EC verification Annex IV  
   - *MD 1107 - Active devices for disinfection and sterilisation
EC verification Annex IV  
   - *MD 1108 - Active rehabilitation devices and active prostheses
EC verification Annex IV  
   - *MD 1109 - Active devices for patient positioning and transport
EC verification Annex IV  
   - *MD 1110 - Active devices for in vitro fertilisation (IVF) and assisted reproductive therapy (ART)
EC verification Annex IV  
   - *MD 1111 - Software
EC verification Annex IV For Class IIa Devices only 
*MD 1200 - Devices for imaging
 
   - *MD 1202 - Imaging devices utilising non-ionizing radiation
EC verification Annex IV Excluding Laser Devices Excluding Radionuclide and Magnetic Resonance Imaging 
*MD 1300 - Monitoring devices
 
   - *MD 1301 - Monitoring devices of non-vital physiological parameters
EC verification Annex IV  
*MD 1400 - Devices for radiation therapy and thermo therapy
 
   - *MD 1402 - Devices utilising non-ionizing radiation
EC verification Annex IV  
   - *MD 1403 - Devices for hyperthermia / hypothermia
EC verification Annex IV  
   - *MD 1404 - Devices for (extracorporal) shock-wave therapy (lithotripsy)
EC verification Annex IV  
 
Horizontal technical competence Limitations
*MDS 7004 - Medical devices referencing the Directive 2006/42/EC on machinery  
*MDS 7006 - Medical devices in sterile condition  
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