Summary for ARTG Entry:
BMC CPAP Pty Ltd - Sleep apnoea nasal mask, reusable
ARTG entry for
Medical Device Included Class IIa
BMC CPAP Pty Ltd
PO Box 3007,ROUSE HILL, NSW, 2155
ARTG Start Date
Medical Device Class IIa
- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,
Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations
2002 for relevant information.
- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal
offence; and civil penalties may apply.
BMC Medical Co
Room 110 Tower A Fengyu Building No 115
Fucheng Road Haidian
, Beijing, 100036
1. Sleep apnoea nasal mask, reusable
Medical device system
36033 Sleep apnoea nasal mask, reusable
A flexible, form-shaped device placed over the nose and designed to direct ambient air, or oxygen (O2)
and air, into the respiratory tract, at a higher pressure than ambient air, to provide positive pressure [e.g.,
continuous positive airway pressure (CPAP), or bi-level positive airway pressure (BiPAP)] to
improve/enhance the sleep of persons experiencing sleep apnoea. It is typically made of plastic, silicone,
or other materials that create an airtight seal around the nasal passages. It typically includes a standard 22
mm connector (adult) or a 15 mm connector (paediatric), and is available in various designs and sizes. It
may be stabilized with a headstrap. This is a reusable device.
No Specific Conditions included on Record
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