Medical device licence · 115560 · Class 3
COBAS CLICK SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed June 10, 2026. It is in Health Canada’s list of active licences.
- Licence number
- 115560
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- June 10, 2026
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COBAS CLICK
- COBAS HBA1C CONTROL GEN. 2
- COBAS HBA1C TEST GEN. 2
- COBAS LIPID CONTROL GEN. 2
- COBAS LIPID PANEL GEN. 2
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.