Company Quality Certifications

Logo TUV ISO9001GEM srl obtained the following Quality Certifications released by TUV Product Service in 2006:

  • EN ISO 13485:2016
  • UNI EN ISO 9001:2015
  • Medical Device Single Audit Program (MDSAP)

 

Products Certifications

The Medical Devices Glubran 2, Glubran Tiss, Dispensing Tip, Drop Control Device are CE 0373 certificated (Istituto Superiore della Sanità Italiana).

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Catheter for Laparoscopy, Spray Device and Glutack are certified CE 1936 (TÜV Rheinland).

The medical device Glubran 2 Seal Device is certified CE 0476 (CERMET).

 

All devices obtained the Canadian Licence and the Australian TGA.

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