Medical device licence · 93643 · Class 2
Z2 AUTO CPAP SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed July 25, 2014. It is in Health Canada’s list of active licences.
- Licence number
- 93643
- Licence holder
- Breas Medical AbMolnlycke, Sweden
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- July 25, 2014
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- 4 FOOT SLIMSTYLE TUBE
- DC MOBILE ADAPTER
- EXTENDED LIFE BATTERY
- HEAT MOISTURE EXCHANGER
- Z2 CUSTOM TUBE ADAPTER
- Z2 CUSTOM USB CABLE
- Z2 PLASTIC FILTER ENDCAP
- Z2 POLYESTER FILTER
- Z2 POWER SUPPLY
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.