Medical device licence · 108502 · Class 3
OPTUNE GIO
Yes: licensed in Canada
Licence status Issued (active); first licensed November 8, 2022. It is in Health Canada’s list of active licences.
- Licence number
- 108502
- Licence holder
- Novocure GmbhBaar, Switzerland
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- November 8, 2022
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- OPTUNE HFE TRANSDUCER ARRAY
- OPTUNE SYSTEM
- OPTUNE SYSTEM - CAD
- OPTUNE SYSTEM - CHARGER
- OPTUNE SYSTEM - POWER SUPPLY
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.