Medical device licence · 113089 · Class 2
BIWAZE COUGH
Yes: licensed in Canada
Licence status Issued (active); first licensed April 11, 2025. It is in Health Canada’s list of active licences.
- Licence number
- 113089
- Licence holder
- Abmrc LlcEagan, MN, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- April 11, 2025
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BIWAZE COUGH
- BIWAZE COUGH - ACUTE CARE SYSTEM
- BIWAZE COUGH - HOME CARE SYSTEM
- BIWAZE COUGH DUAL LUMEN CIRCUIT WITH FACE MASK
- BIWAZE COUGH DUAL LUMEN CIRCUIT WITH MOUTHPIECE
- BIWAZE COUGH DUAL LUMEN CIRCUIT WITH TRACH ADAPTER
- BIWAZE COUGH REMOTE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.