Medical device licence · 114095 · Class 3
VITALFLOW SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed October 7, 2025. It is in Health Canada’s list of active licences.
- Licence number
- 114095
- Licence holder
- Mc3, Inc.Dexter, MI, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- October 7, 2025
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- NAUTILUS VF OXYGENATOR CABLE
- VITALFLOW CONSOLE
- VITALFLOW EMERGENCY HANDCRANK
- VITALFLOW FLOW AND BUBBLE SENSOR
- VITALFLOW MOTORDRIVE
- VITALFLOW POWER CORD
- VITALFLOW SET WITH BALANCE BIOSURFACE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.