Medical device licence · 106929 · Class 2
THERAPY MASK 3100 SP
Yes: licensed in Canada
Licence status Issued (active); first licensed November 4, 2021. It is in Health Canada’s list of active licences.
- Licence number
- 106929
- Licence holder
- Respironics Inc.Murrysville, PA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- November 4, 2021
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- THERAPY MASK 3100 SP, FITPACK, W/HGR
- THERAPY MASK 3100 SP, LAB FITPACK
- THERAPY MASK 3100 SP, W/HGR
- THERAPY MASK 3100 SP, W/O HGR
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.