Pure Global

CPAP/BiPAP face mask, reusable

Access comprehensive regulatory information for CPAP/BiPAP face mask, reusable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Resmed Pty Ltd, manufactured by Resmed Pty Ltd in Australia. The device registration started on April 10, 2024.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.

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TGA ARTG Official Data
Class IIb
Class IIb
CPAP/BiPAP face mask, reusable
Australia TGA ARTG Registered Device
Good Name: Resmed Pty Ltd - CPAP/BiPAP face mask, reusable
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Intended Purpose

The mask is intended to provide an interface for application of non-invasive bi-level or continuous positive airway pressure support therapy.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
April 10, 2024
Effective Date
April 10, 2024
Sponsor
Manufacturer
Country
Australia
Address
1 Elizabeth Macarthur Drive, BELLA VISTA, NSW, 2153