Medical device licence · 111241 · Class 3
COBAS PULSE SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed May 15, 2024. It is in Health Canada’s list of active licences.
- Licence number
- 111241
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- May 15, 2024
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COBAS GLU LINEARITY KIT
- COBAS GLU QC KIT
- COBAS GLU TEST STRIPS
- COBAS PULSE
- COBAS PULSE BATTERY PACK
- COBAS PULSE CHARGING STATION
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.