Medical device licence · 109262 · Class 2
AFIAS CORTISOL
Yes: licensed in Canada
Licence status Issued (active); first licensed April 27, 2023. It is in Health Canada’s list of active licences.
- Licence number
- 109262
- Licence holder
- Boditech Med Inc.Chuncheon-Si, South Korea
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- April 27, 2023
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AFIAS CORTISOL
- BODITECH CORTISOL CALIBRATOR
- BODITECH CORTISOL CONTROL
- BODITECH HORMONE CALIBRATOR
- BODITECH HORMONE CONTROL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.