Medical device licence · 88384 · Class 3
ELECSYS HE4
Yes: licensed in Canada
Licence status Issued (active); first licensed March 5, 2012. It is in Health Canada’s list of active licences.
- Licence number
- 88384
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- Test Kit
- First licensed
- March 5, 2012
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ELECSYS HE4
- HE4 CALSET
- PRECICONTROL HE4
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.