Medical device licence · 108175 · Class 2
ARCTIC SUN STAT TEMPERATURE MANAGEMENT SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed August 16, 2022. It is in Health Canada’s list of active licences.
- Licence number
- 108175
- Licence holder
- Medivance, Inc.Louisville, CO, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- August 16, 2022
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ARCTIC SUN STAT TEMPERATURE MANAGEMENT SYSTEM
- ARCTIC SUN STAT TEMPERATURE MANAGEMENT SYSTEM FILL TUBE
- ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM - FLUID DELIVERY LINE
- ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM - TEMP OUT CABLE
- ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM TEMPERATURE CABLE
- POWER CORD
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.