Medical device licence · 93713 · Class 2
CPAP/VPAP MASKS
Yes: licensed in Canada
Licence status Issued (active); first licensed August 11, 2014. It is in Health Canada’s list of active licences.
- Licence number
- 93713
- Licence holder
- Hsiner Co. Ltd.Taichung, Taiwan
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group Family
- First licensed
- August 11, 2014
- Devices covered
- 18
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CPAP NASAL MASK
- CPAP SILICONE FACE MASK
- CPAP SILICONE FULL FACE MASK
- CPAP SILICONE NASAL MASK
- CPAP TOTAL FULL FACE MASK
- HIGH FLOW NASAL CANNULA
- INFANT CPAP CANNULA
- INFANT NASAL CPAP MASK
- INFANT NV NASAL MASK
- NASAL PILLOW MASK
- NIPPV SILICONE FACE MASK
- NIPPV SILICONE NASAL MASK
- NV SILICONE FACE MASK
- NV SILICONE FULL FACE MASK
- NV SILICONE NASAL MASK
- NV SILICONE TOTAL FULL FACE MASK
- VPAP FACE MASK
- VPAP TOTAL FULL FACE MASK
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.