Navigation path


Notification

Found : 23
  Body (History):

UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi Sanayi ve Ticaret Limited Sirketi
Turan Gunes Bulvari Korman Sitesi 51/M Yildiz-Cankaya/Ankara
Ankara
Country : Turkey

Phone : 00 90 312 443 03 90
Fax : 00 90 312 443 03 76

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

Notified Body number : 2292

Version(s): 1 2 3

Last update : 13/06/2012
 

Return to legislation list

Some information about the accreditation details are available in the PDF
Legislation
93/42/EEC Medical devices    
Last update : 11/03/2014                 Version(s): 1 2

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
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
 
   - *MD 0102 - Non-active devices for injection, infusion, transfusion and dialysis
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
 
   - *MD 0103 - Non-active orthopaedic and rehabilitation devices
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
 
   - *MD 0104 - Non-active medical devices with measuring function
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
 
   - *MD 0105 - Non-active ophthalmologic devices
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
 
   - *MD 0106 - Non-active instruments
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
 
   - *MD 0107 - Contraceptive medical devices
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
 
   - *MD 0108 - Non-active medical devices for disinfecting, cleaning, rinsing
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
 
   - *MD 0109 - Non-active devices for in vitro fertilisation (IVF) and assisted reproductive technologies (ART)
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
 
*MD 0200 - Non-active implants
 
   - *MD 0201 - Non-active cardiovascular implants
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
 
   - *MD 0202 - Non-active orthopaedic implants
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
 
   - *MD 0203 - Non-active functional implants
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
 
   - *MD 0204 - Non-active soft tissue implants
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
 
*MD 0300 - Devices for wound care
 
   - *MD 0301 - Bandages and wound dressings
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
 
   - *MD 0302 - Suture material and clamps
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
 
   - *MD 0303 - Other medical devices for wound care
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
 
*MD 0400 - Non-active dental devices and accessories
 
   - *MD 0401 - Non-active dental equipment and instruments
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
 
   - *MD 0402 - Dental materials
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
 
   - *MD 0403 - Dental implants
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
 
Set page to normal font size Increase font size by 200 percentprint this page