Medical device licence · 104757 · Class 2
BREATHID SMART SYSTEM
Yes: licensed in Canada
Licence status Issued with conditions; first licensed June 9, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 104757
- Licence holder
- Meridian Bioscience Israel Ltd.Modiin, Israel
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- June 9, 2020
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- 13C-UREA
- BREATHID HP BASELINE BREATH SAMPLE BAG
- BREATHID HP POST INGESTION BREATH SAMPLE BAG
- BREATHID SMART
- BREATHID SYSTEM TEST CARTRIDGE
- CRITICA
- IDKIT HP TWO
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.