Medical device licence · 76419 · Class 2
LACTATE
Yes: licensed in Canada
Licence status Issued (active); first licensed February 20, 2008. It is in Health Canada’s list of active licences.
- Licence number
- 76419
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- February 20, 2008
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- LACT2 (LACTATE GEN.2)
- LACTATE GEN.2 FOR COBAS C111
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.