Medical device licence · 108897 · Class 2
ONEAPP
Yes: licensed in Canada
Licence status Issued (active); first licensed February 16, 2023. It is in Health Canada’s list of active licences.
- Licence number
- 108897
- Licence holder
- Sbo Hearing ASmorum, Denmark
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- February 16, 2023
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BERNAFON APP
- OTICON COMPANION
- PHILIPS HEARLINK 2
- SONIC SOUNDLINK 3
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.