CPAP/BiPAP face mask, reusable - ARTG 480813
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 IIa is registered under ARTG number 480813 and sponsored by Plus Medical Pty Ltd, manufactured by Suzhou Yuyue Medical Technology Co Ltd in China. The device registration started on February 25, 2025.
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.
Sleep apnea breathing mask, CPAP/BiPAP masks are used in conjunction with CPAP and BiPAP. The masks are flexible, face and form-shaped devices designed to be placed over a client's nose and mouth to interface with a 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.