Medical device licence · 104302 · Class 3
OR3O DUAL MOBILITY SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed February 14, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 104302
- Licence holder
- Smith & Nephew, Inc.Mississauga, Ontario, Canada
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- February 14, 2020
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- OR3O DUAL MOBILITY INSERT XLPE
- OR3O DUAL MOBILITY LINER
- OR3O DUAL MOBILITY TRIAL INSERT
- OR3O DUAL MOBILITY TRIAL LINER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.