Medical device licence · 552 · Class 3
ELITE MODULAR SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed December 29, 1998. It is in Health Canada’s list of active licences.
- Licence number
- 552
- Licence holder
- Depuy Ireland UcRingaskiddy, CK, Ireland
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- December 29, 1998
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ELITE FEMORAL PROSTHESIS - FLANGED 40
- ELITE FEMORAL PROSTHESIS - LONG NECK 1
- ELITE FEMORAL PROSTHESIS - LONG NECK 2
- ELITE FEMORAL PROSTHESIS - MAGNUM 40
- ELITE MODULAR HEAD - EXTRA LONG
- ELITE MODULAR HEAD - LONG NECK
- ELITE MODULAR HEAD - SHORT NECK
- ELITE MODULAR HEAD - STANDARD NECK
- ELITE MULTICUP LPW
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.