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Notification

Found : 38
  Body (History):

Szutest Teknik Kontrol ve Belgelendirme Hizmetleri Ticaret Limited Şirketi
İnönü Mahallesi Kayışdağı Caddesi No: 148 Daire 3-4 Ataşehir /İStanbul/Türkiye
Ataşehir/ISTANBUL
Country : Turkey

Phone : 00 90 216 469 46 66
Fax : 00 90 216 469 46 67

Email : info@szutest.com.tr
Website : www.szutest.com.tr

Notified Body number : 2195

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

Last update : 28/04/2010
 

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Some information about the accreditation details are available in the PDF
Legislation
93/42/EEC Medical devices    
Last update : 24/11/2009
Products Procedures Articles/Annexes Limitations
*MD 0100 - General non-active, non-implantable medical devices
 
   - *MD 0101 - Non-active devices for anaesthesia, emergency and intensive care
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
   - *MD 0102 - Non-active devices for injection, infusion, transfusion and dialysis
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
   - *MD 0103 - Non-active orthopaedic and rehabilitation devices
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
   - *MD 0104 - Non-active medical devices with measuring function
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
   - *MD 0105 - Non-active ophthalmologic devices
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
   - *MD 0106 - Non-active instruments
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
   - *MD 0108 - Non-active medical devices for disinfecting, cleaning, rinsing
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
*MD 0200 - Non-active implants
 
   - *MD 0202 - Non-active orthopaedic implants
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
   - *MD 0203 - Non-active functional implants
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
   - *MD 0204 - Non-active soft tissue implants
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
*MD 0300 - Devices for wound care
 
   - *MD 0301 - Bandages and wound dressings
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
   - *MD 0302 - Suture material and clamps
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
   - *MD 0303 - Other medical devices for wound care
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
*MD 0400 - Non-active dental devices and accessories
 
   - *MD 0401 - Non-active dental equipment and instruments
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
   - *MD 0402 - Dental materials
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
   - *MD 0403 - Dental implants
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
*MD 1100 - General active medical devices
 
   - *MD 1101 - Devices for extra-corporal circulation, infusion and haemopheresis
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
   - *MD 1102 - Respiratory devices, devices including hyperbaric chambers for oxygen therapy, inhalation anaesthesia
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
   - *MD 1103 - Devices for stimulation or inhibition
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
   - *MD 1104 - Active surgical devices
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
   - *MD 1105 - Active ophthalmologic devices
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
   - *MD 1106 - Active dental devices
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
   - *MD 1107 - Active devices for disinfection and sterilisation
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
   - *MD 1111 - Software
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
*MD 1200 - Devices for imaging
 
   - *MD 1201 - Imaging devices utilising ionizing radiation
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
   - *MD 1202 - Imaging devices utilising non-ionizing radiation
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
*MD 1300 - Monitoring devices
 
   - *MD 1301 - Monitoring devices of non-vital physiological parameters
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
   - *MD 1302 - Monitoring devices of vital physiological parameters
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
*MD 1400 - Devices for radiation therapy and thermo therapy
 
   - *MD 1401 - Devices utilising ionizing radiation
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
   - *MD 1402 - Devices utilising non-ionizing radiation
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
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