Medical device licence · 105962 · Class 2
BIOPHEN DIXAI
Yes: licensed in Canada
Licence status Issued (active); first licensed March 24, 2021. It is in Health Canada’s list of active licences.
- Licence number
- 105962
- Licence holder
- Hyphen BiomedNeuville Sur Oise, France
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- March 24, 2021
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BIOPHEN DIXAI
- FREEZE-DRIED FACTOR XA-SPECIFIC CHRONOGENIC SUBSTRATE
- HUMAN FACTOR FXA
- REACTION BUFFER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.