Medical device licence · 105965 · Class 3
ALPHA
Yes: licensed in Canada
Licence status Issued (active); first licensed March 29, 2021. It is in Health Canada’s list of active licences.
- Licence number
- 105965
- Licence holder
- Formatk Systems Ltd.Tirat Hacarmel, Israel
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- March 29, 2021
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ALD
- ALPHA
- L-530
- L-650
- LLD
- S-430
- S-530
- S-590
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.