Medical device licence · 114642 · Class 2
COBAS BV/CV
Yes: licensed in Canada
Licence status Issued (active); first licensed January 8, 2026. It is in Health Canada’s list of active licences.
- Licence number
- 114642
- Licence holder
- Roche Molecular Systems, IncBranchburg, NJ, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- January 8, 2026
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COBAS BUFFER NEGATIVE CONTROL KIT
- COBAS BV/CV
- COBAS BV/CV CONTROL KIT
- SW COBAS 5800 BV/CV ASAP, VERSION 1.1.0
- SW COBAS BV ASAP, VERSION 12.1.0
- SW COBAS BV/CV ASAP, VERSION 12.1.0
- SW COBAS CV ASAP, VERSION 12.1.0
- SW COBAS X800 BV/CV ASAP, VERSION 1.1.0
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.