Medical device licence · 3058 · Class 3
COBAS INTEGRA SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed May 28, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 3058
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- May 28, 1999
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COBAS INTEGRA SYSTEM - COBAS INTEGRA 400 PLUS ANALYZER - CLASS 3
- COBAS INTEGRA SYSTEM - SOFTWARE FOR COBAS INTEGRA 800
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.