Medical device licence · 102553 · Class 3
ELECSYS PAPP-A
Yes: licensed in Canada
Licence status Issued (active); first licensed March 19, 2019. It is in Health Canada’s list of active licences.
- Licence number
- 102553
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- Test Kit
- First licensed
- March 19, 2019
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ELECSYS PAPP-A
- PAPP-A CALSET
- PRECICONTROL MATERNAL CARE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.