Medical device licence · 104019 · Class 3
ELECSYS GDF-15
Yes: licensed in Canada
Licence status Issued (active); first licensed December 17, 2019. It is in Health Canada’s list of active licences.
- Licence number
- 104019
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- Test Kit
- First licensed
- December 17, 2019
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CALSET GDF-15
- ELECSYS GDF-15
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.