Public respirator, single-use
Access comprehensive regulatory information for Public respirator, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by SNE International Pty Ltd, manufactured by DANAMECO MEDICAL JOINT STOCK CORPORATION in Vietnam. The device registration started on January 07, 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.
This N95 Respirator is a form-shaped filtering mask designed to be placed over the nose and mouth to permit normal breathing while protecting the wearer from large particles (e.g., blood, body fluids, and airborne particulate materials) and small particles (e.g., bacteria and viruses) when considered necessary (e.g., viral epidemic). It is a soft, flexible mask that will create an airtight seal against the user’s face and secured using elastic head straps or ties with a forming nosepiece (metal wire). The product meets the requirements of the EN 149:2001+A1:2009 standards. This is a single-use device.