Medical device licence · 107095 · Class 2
BIOPHEN FACTOR IX
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
- 107095
- 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
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ACTIVATOR REAGENT
- BIOPHEN FACTOR IX
- BUFFER
- FX(H)-FVIII:C
- SUBSTRATE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.