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 IIa is sponsored by Emergo Asia Pacific Pty Ltd T/a Emergo Australia, manufactured by Apex Medical Corp in Taiwan. The device registration started on July 09, 2015.
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.
The Full Face Mask is intended for use in the home environment, hospitals and care facilities by adult patients (more than 30 kg) for whom positive airway pressure (CPAP or bi-level system) has been prescribed.