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Notification

Found : 8
  Body :

CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft.
Gyár u. 2.
Budaörs
Country : Hungary

Phone : 00-36-23-880-830
Fax : 00-36-23-880-831

Email : info@cecertiso.hu
Website : www.cecertiso.hu

Notified Body number : 2409

Last update : 17/09/2012
 

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Some information about the accreditation details are available in the PDF
Legislation
98/79/EC In vitro diagnostic medical devices    
Last update : 25/09/2012
Products Procedures Articles/Annexes Limitations
*IVD 0300 - Reagents, reagent products and devices for self-diagnosis, including related calibrators and control materials, for determining, detection, quantification, diagnosing, evaluating
 
   - *IVD 0307 - Tumoral marker: PSA
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex IV
Annex VII
 
   - *IVD 0308 - Risk of trisomy 21 (incl. software)
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex IV
Annex VII
 
   - *IVD 0309 - Device for self-diagnosis: device for the measurement of blood sugar
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex IV
Annex VII
 
*IVD 0400 - Devices for self-testing
 
   - *IVD 0401 - Clinical chemistry
EC declaration of conformity
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex III
Annex IV
Annex VII
 
   - *IVD 0405 - Pregnancy and ovulation
EC declaration of conformity
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex III
Annex IV
Annex VII
 
   - *IVD 0406 - Specimen receptacles
EC declaration of conformity
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex III
Annex IV
Annex VII
 
 
Horizontal technical competence Limitations
*MDS 7206 - IVDs in sterile condition  
*MDS 7209 - IVDs utilising biological active coating and/or material  
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