Medical device licence · 71083 · Class 2
CHEMISTRY ANALYZERS
Yes: licensed in Canada
Licence status Issued (active); first licensed April 11, 2006. It is in Health Canada’s list of active licences.
- Licence number
- 71083
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- April 11, 2006
- Devices covered
- 7
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-C 501 STAND ALONE CONFIGURATION
- COBAS 8000 C502 STAND ALONE CONFIGURATION
- COBAS 8000 C701 STAND ALONE CONFIGURATION
- COBAS 8000 C702 STAND ALONE CONFIGURATION
- MODULAR D2400 ANALYZER
- MODULAR EVO D2400 ANALYZER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.