Medical device licence · 114532 · Class 3
SIRIUS PINTUITION
Yes: licensed in Canada
Licence status Issued (active); first licensed December 18, 2025. It is in Health Canada’s list of active licences.
- Licence number
- 114532
- Licence holder
- Sirius Medical Systems B.V.Eindhoven, Netherlands
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- December 18, 2025
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- SIRIUS PINTUITION BASE UNIT
- SIRIUS PINTUITION PROBE
- SIRIUS PINTUITION SEED
- SIRIUS PINTUITION SLIM PROBE
- SIRIUS PINTUITION SLIM TEST KIT
- SIRIUS PINTUITION TEST KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.