Medical device licence · 107096 · Class 2
FACTOR IX DEFICIENT PLASMA
Yes: licensed in Canada
Licence status Issued (active); first licensed December 2, 2021. It is in Health Canada’s list of active licences.
- Licence number
- 107096
- Licence holder
- Hyphen BiomedNeuville Sur Oise, France
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- December 2, 2021
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CITRATED HUMAN PLASMA
- FACTOR IX DEFICIENT PLASMA
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.