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)
Products Certifications
Glubran 2 Medical Device is CE 0373 certified (Istituto Superiore della Sanità Italiana).
Catheter for Laparoscopy, Spray Device and Glutack are certified CE 1936 (TÜV Rheinland).
The Medical Devices Glubran Tiss 2, Dispensing Tip and Drop control Device are CE 0425 (ICIM) certified
All devices obtained the Canadian Licence, the Australian TGA and Anvisa.
