Medical device licence · 110065 · Class 3
GENEO X
Yes: licensed in Canada
Licence status Issued (active); first licensed September 20, 2023. It is in Health Canada’s list of active licences.
- Licence number
- 110065
- Licence holder
- Pollogen Ltd.Tel Aviv, Israel
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- September 20, 2023
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- GENEO X
- GENEO X TRIPOLLAR KIT
- GENEO X ULTRASOUND KIT
- GX APPLICATOR OXYGENEO ASSY
- GX APPLICATOR TRIPOLLAR ASSY
- GX APPLICATOR US ASSY
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.