Medical device licence · 109213 · Class 2
D-DIMER
Yes: licensed in Canada
Licence status Issued (active); first licensed April 13, 2023. It is in Health Canada’s list of active licences.
- Licence number
- 109213
- Licence holder
- Biokit S.A.Lliçà D'Amunt, 08, Spain
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- April 13, 2023
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- D-DIMER
- D-DIMER CALIBRATOR
- D-DIMER CONTROLS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.