Medical device licence · 114372 · Class 2
IMRS PRIME
Yes: licensed in Canada
Licence status Issued (active); first licensed November 25, 2025. It is in Health Canada’s list of active licences.
- Licence number
- 114372
- Licence holder
- Swiss Bionic Solutions Schweiz GmbhSchindellegi, Switzerland
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- November 25, 2025
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- EXAGON FIR
- EXAGON MAT
- EXAGON PAD
- EXAGON SPOT
- IMRS PRIME CONNECTORBOX
- IMRS PRIME CONTROL UNIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.