Medical device licence · 111366 · Class 2
KARDIOBEAT.AI
Yes: licensed in Canada
Licence status Issued (active); first licensed June 11, 2024. It is in Health Canada’s list of active licences.
- Licence number
- 111366
- Licence holder
- Medicalgorithmics S.A.Warsaw, Poland
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- June 11, 2024
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- KARDIOBEAT.AI CONNECT
- KARDIOBEAT.AI INIT
- KARDIOBEAT.AI RECORDER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.