Medical device licence · 98002 · Class 2
CPAP MASKS
Yes: licensed in Canada
Licence status Issued (active); first licensed November 9, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 98002
- Licence holder
- Sunset Healthcare SolutionsChicago, IL, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- November 9, 2016
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DELUXE FULL FACE CPAP MASK
- DELUXE FULL FACE MASK REPLACEMENT CUSHION
- DELUXE NASAL CPAP MASK
- DELUXE NASAL MASK REPLACEMENT CUSHION
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.