Medical device licence · 114821 · Class 2
AMA-M2
Yes: licensed in Canada
Licence status Issued (active); first licensed February 6, 2026. It is in Health Canada’s list of active licences.
- Licence number
- 114821
- Licence holder
- Orgentec Diagnostika GmbhMainz, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- February 6, 2026
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AMA-M2
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.