CPAP/BiPAP face mask, reusable - ARTG 326042
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 326042 and sponsored by Wiselink Group Pty Ltd, manufactured by Guangzhou Hypnus Healthcare Co Ltd in China. The device registration started on November 08, 2019.
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 CPAP mask channels airflow noninvasively to patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or Bi-level system. The CPAP mask is to be used by patients (weighting>30kg) for whom positive airway pressure therapy has been prescribed and intended for single-patient reuse in the home environment and multi-patient reuse in the hospital/institutional environment.