Medical device licence · 101363 · Class 3
GMK UNI
Yes: licensed in Canada
Licence status Issued (active); first licensed July 6, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 101363
- Licence holder
- Medacta International SaCastel San Pietro, Switzerland
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- July 6, 2018
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- GMK UNI - ANATOMIC FEMORAL COMPONENT - CEMENTED
- GMK UNI - FIXED PLUS TIBIAL TRAY - CEMENTED
- GMK UNI - FIXED TIBIAL INSERT
- GMK UNI - FIXED TIBIAL TRAY - CEMENTED
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.