Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Emergo Asia Pacific Pty Ltd T/a Emergo Australia - CPAP/BiPAP face mask, reusable
ARTG entry for
Medical Device Included Class IIa
Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Level 20 Tower II Darling Park 201 Sussex Street,SYDNEY, NSW, 2000
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. CPAP/BiPAP face mask, reusable
Single Device Product
57814 CPAP/BiPAP face mask, reusable
The Full Face Mask channels airflow non-invasively to a patient from a positive airway pressure device
such as a continuous positive airway pressure (CPAP) or bi-level system.
The Full Face Mask is:
· to be used by adult patients (greater than 66 lb / 30 kg) for whom positive airway pressure therapy has
· intended for single-patient re-use in the home environment and multi-patient re-use in the hospital /
No Specific Conditions included on Record
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Produced at 01.12.2017 at 11:22:07 AEDT
This is not an ARTG Certificate document.
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