Summary for ARTG Entry:
BMC CPAP Pty Ltd - 44521 - Sleep apnoea face 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. 44521 - Sleep apnoea face mask, reusable
Medical device system
44521 Sleep apnoea face mask, reusable
The BMC Full Face Mask channels airflow non-evasively to a patient from a positive airway pressure
device such as a continuous positive airway pressure (CPAP) or bi-level system. The BMC Full Face Mask
* to be used by adult patients (>30kg) from whom positive airway pressure therapy as been prescribed.
* intended for single-patient re-use in the home environment and multi-patient re-use in the
No Specific Conditions included on Record
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