Medical device licence · 114610 · Class 4
ELECSYS HBEAG QUANT
Yes: licensed in Canada
Licence status Issued (active); first licensed January 5, 2026. It is in Health Canada’s list of active licences.
- Licence number
- 114610
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class IV (highest risk)
- Licence type
- Test Kit
- First licensed
- January 5, 2026
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ELECYS HBEAG QUANT
- PRECICONTROL HBEAG QUANT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.