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 Freyr Australia Pty Ltd, manufactured by Suzhou Yuyue Medical Technology Co Ltd in China. The device registration started on September 21, 2022.
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 mask is a noninvasive accessory used for channeling airflow (With or without supplemental oxygen) to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bi-level system. > The mask is to be used by patients (weighing>30kg), intended for single-patient reuse in the home environment. > The mask is intended for single-patient use in the hospital or institutional environment.