Medical device licence · 81175 · Class 2
PATIENT MANAGEMENT SOFTWARE
Yes: licensed in Canada
Licence status Issued (active); first licensed November 10, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 81175
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- November 10, 2009
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COBAS 8000 DATA MANAGER
- COBAS INFINITY CENTRAL LAB
- COBAS IT 1000 SOFTWARE
- COBAS IT MIDDLEWARE
- NAVIFY LAB OPERATIONS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.