Medical device licence · 13354 · Class 2
CPAP MASKS
No longer licensed: suspended: invalid quality-system certificate
Licence status Suspended: invalid quality-system certificate; first licensed October 29, 1999; ended November 30, 2020. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 13354
- Licence holder
- Vyaire Medical FormerlyYorba Linda, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- October 29, 1999
- Ended
- November 30, 2020
- Devices covered
- 12
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ADV. FULL FACEMASK
- ADV. FULL FACEMASK NON-VENT
- ADV. SERIES MASK
- ADV. SERIES NON-VENT MASK
- CPAP MASKS
- FULL ADV. MASK NON-VENT
- FULL ADV. MASK-ANTIV
- NASAL BELLOWS BODY MASK
- NCPAP MASK V.SWIVEL
- PURESOM NASAL MASK
- SNAPP-X NASAL BELLOWS BODY MASK
- SNAPP-X W/ADJ HEADGEAR MASK
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.