Medical device licence · 98824 · Class 3
COBAS DPX
Yes: licensed in Canada
Licence status Issued (active); first licensed March 21, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 98824
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- March 21, 2017
- 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 DPX
- COBAS DPX CONTROL KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.