Medical device licence · 67268 · Class 2
CPAP MASKS
Yes: licensed in Canada
Licence status Issued (active); first licensed February 1, 2005. It is in Health Canada’s list of active licences.
- Licence number
- 67268
- Licence holder
- Fisher And Paykel Healthcare Ltd.Auckland, New Zealand
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- February 1, 2005
- Devices covered
- 26
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ESON NASAL MASK
- EVORA NASAL MASK - FIT PACK
- F&P BREVIDA NASAL PILLOW MASK
- F&P ESON 2 NASAL MASK
- F&P ESON 2 NASAL MASK - FIT PACK S/M/L
- F&P EVORA FULL FACE PAP THERAPY MASK
- F&P EVORA FULL FACE PAP THERAPY MASK- FIT PACK
- F&P EVORA NASAL MASK
- F&P PILAIRO Q NASAL PILOWS MASK
- F&P SIMPLUS FULL FACE MASK
- F&P SIMPLUS FULL FACE MASK - FIT PACK S/M/L
- F&P VITERA FULL FACE MASK
- F&P VITERA FULL FACE MASK
- FLEXIFIT 405 NASAL MASK
- FLEXIFIT 407 NASAL MASK
- FLEXIFIT 432 FULL FACE MASK
- FLEXIFIT SERIES HC431 FULL FACE MASK
- FORMA FULL FACE MASK
- OPUS NASAL PILLOWS MASK
- ORACLE 452 ORAL MASK
- PETITE NASAL MASK
- PLUS NASAL MASK
- STANDARD NASAL MASK
- ZEST NASAL MASK
- ZEST PETITE NASAL MASK
- ZEST PLUS NASAL MASK
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.