Medical device licence · 82702 · Class 2
COBAS INSTRUMENT SOFTWARE
Yes: licensed in Canada
Licence status Issued (active); first licensed April 28, 2010. It is in Health Canada’s list of active licences.
- Licence number
- 82702
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Single Device
- First licensed
- April 28, 2010
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COBAS PRO INTEGRATED SOLUTIONS INSTRUMENT SOFTWARE VERSION 03-01
- COBAS PRO INTEGRATED SOLUTIONS SYSTEM SOFTWARE INSTALLATION CD
- COBAS PURE INTEGRATED SOLUTIONS INSTRUMENT SOFTWARE VERSION 01-01
- COBAS PURE INTEGRATED SOLUTIONS INSTRUMENT SOFTWARE VERSION 01-02
- MODULAR ANALYZER SERIES COBAS 8000 SOFTWARE VERSION 06-02
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.