Medical device licence · 101600 · Class 2
BIOPHEN DIXAI
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed August 14, 2018; ended October 29, 2020. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 101600
- Licence holder
- Hyphen BiomedNeuville Sur Oise, France
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- August 14, 2018
- Ended
- October 29, 2020
- 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.