Medical device licence · 85574 · Class 2
AOTI HYPER-BOX SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed March 22, 2011. It is in Health Canada’s list of active licences.
- Licence number
- 85574
- Licence holder
- Aoti Ltd.Galway, Ireland
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- March 22, 2011
- Devices covered
- 10
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AOTI HYPER-BOX SYSTEM - 20 LITRE OXYGEN BOTTLE
- AOTI HYPER-BOX SYSTEM - CONTROLLER
- AOTI HYPER-BOX SYSTEM - DISPOSABLE CHAMBER
- AOTI HYPER-BOX SYSTEM - MAIN UNIT
- AOTI HYPER-BOX SYSTEM - OXICLIP PRESSURE REDUCING VALVE
- AOTI HYPER-BOX SYSTEM - PRESSURE REGULATOR, PLUG TYPE
- AOTI HYPER-BOX SYSTEM - REUSABLE CHAMBER
- AOTI HYPER-BOX SYSTEM - SACRAL DISPOSABLE CHAMBER
- AOTI HYPER-BOX SYSTEM - SLEEVES DISPOSABLE
- AOTI HYPER-BOX SYSTEM - SLEEVES REUSABLE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.