Medical device licence · 115534 · Class 3
COBAS RESPIRATORY FLEX
Yes: licensed in Canada
Licence status Issued with conditions; first licensed June 10, 2026. It is in Health Canada’s list of active licences.
- Licence number
- 115534
- Licence holder
- Roche Molecular Systems, IncBranchburg, NJ, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Test Kit
- First licensed
- June 10, 2026
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COBAS BUFFER NEGATIVE CONTROL KIT
- COBAS RESPIRATORY FLEX
- COBAS RESPIRATORY FLEX CONTROL KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.