CPAP/BiPAP face mask, reusable

Australia - English - Department of Health (Therapeutic Goods Administration)

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Available from:
Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Class IIa
Authorization status:
Authorization number:

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Public Summary

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

Postal Address

Level 20 Tower II Darling Park 201 Sussex Street,SYDNEY, NSW, 2000


ARTG Start Date


Product category

Medical Device Class IIa



Approval area

Medical Devices


- 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

Product Type

Single Device Product

Effective date



57814 CPAP/BiPAP face mask, reusable

Intended purpose

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

been prescribed.

· intended for single-patient re-use in the home environment and multi-patient re-use in the hospital /

institutional environment.

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at

Public Summary

Page 1 of

Produced at 01.12.2017 at 11:22:07 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

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