Medical device licence · 114607 · Class 2
IONIFY ANTIBIOTICS 2
Yes: licensed in Canada
Licence status Issued (active); first licensed January 2, 2026. It is in Health Canada’s list of active licences.
- Licence number
- 114607
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- January 2, 2026
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- IONIFY ANTIBIOTICS 2
- IONIFY CALSET TDM C
- IONIFY CONTROLSET TDM C
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.