Medical device licence · 109532 · Class 2
ORTHOFX RESCUE ALIGNER
Yes: licensed in Canada
Licence status Issued (active); first licensed June 15, 2023. It is in Health Canada’s list of active licences.
- Licence number
- 109532
- Licence holder
- Smylio IncorporatedFremont, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Single Device
- First licensed
- June 15, 2023
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ORTHOFX RESCUE ALIGNER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.