Australia TGA ARTG record

CPAP/BiPAP face mask, reusable

Australia TGA ARTG Registered Device · Resmed Pty Ltd · Resmed Pty Ltd · Class IIb · Started April 10, 2024

Good Name: Resmed Pty Ltd - CPAP/BiPAP face mask, reusable

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

Name: Resmed Pty Ltd

Manufacturer

Name: Resmed Pty Ltd
Country: Australia
Address: 1 Elizabeth Macarthur Drive, BELLA VISTA, NSW, 2153

Intended purpose

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

About this record

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.