Medical device licence · 101529 · Class 2
FUSION BX
Yes: licensed in Canada
Licence status Issued (active); first licensed July 30, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 101529
- Licence holder
- Focal Healthcare Inc.Toronto, ON, Canada
- Risk class
- Class II (low to moderate risk)
- Licence type
- Single Device
- First licensed
- July 30, 2018
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- FUSION BX
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.