Surgical/medical respirator, single-use
Access comprehensive regulatory information for Surgical/medical respirator, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Plus Medical Pty Ltd, manufactured by Rizhao Sanqi Medical & Health Articles Co Ltd in China. The device registration started on February 06, 2023.
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.
A filtering mask [N95(filter efficiency 95%)] designed to be placed over the nose and mouth to permit normal breathing while protecting the wearer from exposure to pathogenic biological airborne particulates and blood spurts during a public health medical emergency (eg. influenza pandemic). It is typically made from multiple layers of non-woven polymers, and incorporates a forming nose piece (metal wire); it is typically secured using elastic head straps. This is a single-use device.