Medical device licence · 112585 · Class 3
SENTIO SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed January 23, 2025. It is in Health Canada’s list of active licences.
- Licence number
- 112585
- Licence holder
- Oticon Medical AbAskim, Sweden
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- January 23, 2025
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- SENTIO 1 MINI, CBE
- SENTIO 1 MINI, CNB
- SENTIO 1 MINI, DBL
- SENTIO 1 MINI, SIL
- SENTIO 1 MINI, STG
- SENTIO 1 MINI, TC
- SENTIO TI IMPLANT KIT
- SPARE FIXATION SCREWS, 3 PCS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.