Medical device licence · 95910 · Class 4
GEENIUS
Yes: licensed in Canada
Licence status Issued (active); first licensed October 15, 2015. It is in Health Canada’s list of active licences.
- Licence number
- 95910
- Licence holder
- Bio-RadMarnes-La-Coquette, 51, France
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- October 15, 2015
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- GEENIUS HIV 1/2 CONFIRMATORY ASSAY
- GEENIUS HIV 1/2 CONFIRMATORY CONTROLS
- GEENIUS SOFTWARE
- GEENIUS SYSTEM - GEENIUS READER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.