Medical device licence · 102612 · Class 2
FITTING SOFTWARE
Yes: licensed in Canada
Licence status Issued (active); first licensed March 21, 2019. It is in Health Canada’s list of active licences.
- Licence number
- 102612
- Licence holder
- Sbo Hearing ASmorum, Denmark
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- March 21, 2019
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- EXPRESSFIT PRO
- OASISNXT
- OTICON GENIE 2
- PHILIPS HEARSUITE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.