CPAP/BiPAP face mask, reusable - ARTG 447951
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 registered under ARTG number 447951 and sponsored by Meditech Systems Asia Pacific Pty Ltd, manufactured by Hsiner Co Ltd in Taiwan. The device registration started on May 07, 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.
CPAP/BiPAP masks are used in conjunction with CPAP and BiPAP therapy for patients who need help recruiting or splinting open their airways. The masks are flexible, face and form-shaped devices designed to be placed over a client's nose and mouth to interface with the aforementioned CPAP or BiPAP unit. They create an airtight seal around the nose and mouth. They are available in various designs and sizes and are stabilized with a head and/or chin strap. This is a reusable device.