Medical device licence · 108441 · Class 2
FRUCTOSAMINE (FRUC)
Yes: licensed in Canada
Licence status Issued (active); first licensed October 24, 2022. It is in Health Canada’s list of active licences.
- Licence number
- 108441
- Licence holder
- Randox Laboratories Ltd.Crumlin, AT, United Kingdom
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- October 24, 2022
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- FRUCTOSAMINE (FRUC)
- FRUCTOSAMINE CALIBRATOR
- FRUCTOSAMINE CONTROL LEVEL 1
- FRUCTOSAMINE CONTROL LEVEL 3
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.