Medical device licence · 76421 · Class 3
CHEMISTRY ANALYZERS
Yes: licensed in Canada
Licence status Issued (active); first licensed February 22, 2008. It is in Health Canada’s list of active licences.
- Licence number
- 76421
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- February 22, 2008
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COBAS 4000 - COBAS C 311 (STAND ALONE CONFIGURATION)
- COBAS 6000 - C501 CHEMISTRY ANALYZER
- COBAS 8000-C502 CHEMISTRY ANALYZER
- COBAS 8000-C701 CHEMISTRY ANALYZER
- COBAS 8000-C702 CHEMISTRY ANALYZER
- MODULAR EVO P800 ANALYZER ADDITIONAL MODULE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.