Medical device licence · 84864 · Class 2
COBAS B 123 SYSTEM
No longer licensed: cancelled
Licence status Cancelled; first licensed January 7, 2011; ended May 31, 2019. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 84864
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- January 7, 2011
- Ended
- May 31, 2019
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COBAS B 123 SYSTEM - FLUID PACK
- COBAS B 123 SYSTEM - FLUID PACK COOX
- COBAS B 123 SYSTEM - MAIN SYSTEM (BASIC VERSION)
- COBAS B 123 SYSTEM - SENSOR CARTRDIGE BG/ISE/GLU/LAC
- COBAS B 123 SYSTEM - SENSOR CARTRIDGE BG
- COBAS B 123 SYSTEM - SENSOR CARTRIDGE BG/ISE
- COBAS B 123 SYSTEM - SENSOR CARTRIDGE BG/ISE/GLU
- COBAS B 123 SYSTEM - SYSTEM SOFTWARE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.