Medical device licence · 97958 · Class 2
OVUSENSE
Yes: licensed in Canada
Licence status Issued (active); first licensed November 14, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 97958
- Licence holder
- Vio Healthtech LimitedCamberley, United Kingdom
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- November 14, 2016
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- OVUCORE VAGINAL SENSOR
- OVUFIRST SKIN WORN SENSOR
- OVUSENSE APP
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.