Medical device licence · 100365 · Class 2
BIOPHEN APIXABAN CONTROL
Yes: licensed in Canada
Licence status Issued (active); first licensed January 9, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 100365
- Licence holder
- Hyphen BiomedNeuville Sur Oise, France
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- January 9, 2018
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BIOPHEN APIXABAN CONTROL
- BIOPHEN APIXABAN CONTROL LOW
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.