CPAP/BiPAP face mask, reusable - ARTG 471308
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 471308 and sponsored by Swirl Technologies Pty Ltd T/A Parker Healthcare, manufactured by Hsiner Co Ltd in Taiwan. The device registration started on December 02, 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.
Mask covers the mouth and nose and is used to connect with a CPAP or BPAP unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation. This is a reusable device.