Medical device licence · 86207 · Class 2
CPAP MASK SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed May 26, 2011. It is in Health Canada’s list of active licences.
- Licence number
- 86207
- Licence holder
- Wellell Inc.New Taipei City, Taiwan
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- May 26, 2011
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- WIZARD 210 NASAL MASK
- WIZARD 220 FULL FACE MASK
- WIZARD 230 NASAL PILLOWS MASK
- WIZARD 310 NASAL MASK WITH HEADGEAR
- WIZARD 320 FULL FACE MASK WITH HEADGEAR
- WIZARD 510 NASAL MASK WITH HEADGEAR
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.