Medical device licence · 109158 · Class 3
VIVO 45 LS
Yes: licensed in Canada
Licence status Issued (active); first licensed April 4, 2023. It is in Health Canada’s list of active licences.
- Licence number
- 109158
- Licence holder
- Breas Medical AbMolnlycke, Sweden
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- April 4, 2023
- Devices covered
- 20
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BREAS XPAC (DUAL) US
- BREAS XPAC (SINGLE) US
- CIRCUIT: FOR SINGLE LIMB MOUTHPIECE VENTILATION (MPV)
- CIRCUIT: SINGLE LIMB
- CIRCUIT: SINGLE LIMB HEATED WIRE
- CLICK-IN BATTERY
- CLICK-IN HUMIDIFIER
- EFFORT BELT COMMUNICATION BOX
- NURSE CALL CABLE
- PATIENT CIRCUIT MPV
- PC SOFTWARE V 1.2
- PTCCO2 CABLE
- REMOTE ALARM CABLE
- REMOTE ALARM UNIT WITH 25M CABLE
- REMOTE ALARM WITH 10M CABLE
- REMOTE START STOP
- SPO2 MODULE
- VIVO 45 LS
- VIVO 45 LS SALES CONFIGURATION WITH CLICK-IN BATTERY
- VIVO 45 LS SALES CONFIGURATION WITHOUT CLICK-IN BATTERY
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.