Medical device licence · 101602 · Class 2
BIOPHEN EDOXABAN CALIBRATORS
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
- 101602
- 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
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BIOPHEN EDOXABAN CALIBRATOR
- BIOPHEN EDOXABAN CALIBRATOR LOW
- CALIBRATOR 1
- CALIBRATOR 2
- CALIBRATOR 3
- CALIBRATOR I
- CALIBRATOR II
- CALIBRATOR III
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.