Medical device licence · 99925 · Class 2
BIOPHEN FIX
Yes: licensed in Canada
Licence status Issued (active); first licensed October 27, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 99925
- Licence holder
- Hyphen BiomedNeuville Sur Oise, France
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- October 27, 2017
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ACTIVATOR REAGENT
- BIOPHEN FIX
- 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.