Company Quality Certifications
GEM 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)
The Medical Devices Glubran 2, Glubran Tiss, Dispensing Tip, Drop Control Device are CE 0373 certificated (Istituto Superiore della Sanità Italiana).
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, the Australian TGA and Anvisa.