Medical device licence · 101603 · Class 2
BIOPHEN DTI
Yes: licensed in Canada
Licence status Issued (active); first licensed August 14, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 101603
- Licence holder
- Hyphen BiomedNeuville Sur Oise, France
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- August 14, 2018
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BIOPHEN DTI
- HUMAN THROMBIN
- THROMBIN SPECIFIC CHROMOGENIC SUBSTRATE
- TRIS-BSA BUFFER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.