Medical device licence · 74389 · Class 2
CHEMISTRY ANALYZERS
Yes: licensed in Canada
Licence status Issued (active); first licensed July 4, 2007. It is in Health Canada’s list of active licences.
- Licence number
- 74389
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- July 4, 2007
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COBAS CIII ANALYZER (WITH ISE)
- COBAS CIII ANALYZER (WITHOUT ISE)
- COBAS INTEGRA 400 PLUS ANALYZER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.