Medical device licence · 101987 · Class 2
SPECTROLYSE PAI-1
Yes: licensed in Canada
Licence status Issued (active); first licensed October 30, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 101987
- Licence holder
- Biomedica Diagnostics Inc.Stamford, CT, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- October 30, 2018
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- SPECTROLYSE PAI-1
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.