Medical device licence · 109681 · Class 3
MAGMA
Yes: licensed in Canada
Licence status Issued (active); first licensed June 29, 2023. It is in Health Canada’s list of active licences.
- Licence number
- 109681
- Licence holder
- Formatk Systems Ltd.Tirat Hacarmel, Israel
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- June 29, 2023
- Devices covered
- 18
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ALD
- B-HR
- B-HR*
- B-SR
- F-AC
- F-HR
- F-HR*
- F-SR
- HR
- HR*
- HR-MAX
- HR-MINI
- LLD
- MAGMA
- ND
- ND TIP KIT
- SHEERWAVE PLUS IPLASER 360
- SR
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.