Medical device licence · 99603 · Class 2
F&P SLEEPSTYLE CPAP
Yes: licensed in Canada
Licence status Issued (active); first licensed September 1, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 99603
- Licence holder
- Fisher And Paykel Healthcare Ltd.Auckland, New Zealand
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- September 1, 2017
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- SLEEPSTYLE CPAP WITH MODEM
- SLEEPSTYLE STANDARD BREATHING TUBE
- SLEEPSTYLE THERMOSMART BREATHING TUBE
- SLEEPSTYLE WATER CHAMBER
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “sleepstyle”. A notice may cover another product or only some lots: read it to see what it covers.
- F&P SleepStyle CPAP Device (2018-03-14)April 3, 2018 · Medical devices · Medical devices · Type III
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.