Medical device licence · 97374 · Class 4
COBAS E 801
Yes: licensed in Canada
Licence status Issued (active); first licensed July 26, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 97374
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- July 26, 2016
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COBAS 8000 E 801
- COBAS E 801 ANALYTICAL UNIT
- COBAS E 801 MSB/MSBL
- COBAS PRO SB
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.