Medical device licence · 95868 · Class 3
COBAS B 101 SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed September 28, 2015. It is in Health Canada’s list of active licences.
- Licence number
- 95868
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- September 28, 2015
- Devices covered
- 11
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COBAS B 101
- COBAS CRP CONTROL
- COBAS CRP TEST
- COBAS HBA1C CONTROL
- COBAS HBA1C CONTROL GEN. 2
- COBAS HBA1C TEST
- COBAS HBA1C TEST GEN. 2
- COBAS LIPID CONTROL
- COBAS LIPID CONTROL GEN. 2
- COBAS LIPID PANEL
- COBAS LIPID PANEL GEN. 2
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.