Medical device licence · 110866 · Class 3
VIVO 1
Yes: licensed in Canada
Licence status Issued (active); first licensed February 26, 2024. It is in Health Canada’s list of active licences.
- Licence number
- 110866
- Licence holder
- Breas Medical AbMolnlycke, Sweden
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- February 26, 2024
- Devices covered
- 20
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ACCESSORY BOX
- BREAS PC SOFTWARE V1.2
- BREAS XPAC (DUAL) US
- BREAS XPAC (SINGLE) US
- EVERYWARE BY BREAS V 3.X.X
- EVERYWARE V 2.1
- HEATED PATIENT CIRCUIT TYPE 2
- HUMIDIFIER CHAMBER FOR VIVO 123
- ILINK
- ILINK
- NURSE CALL CABLE, NC
- NURSE CALL CABLE, NO
- PACKAGED ILINK
- PATIENT CIRCUIT
- PATIENT CIRCUIT: SINGLE PATIENT BREATHING HOSE
- REMOTE ALARM CABLE
- REMOTE ALARM WITH CABLE
- SPO2 MODULE
- VIVO 1
- VIVO CA
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.