Australia TGA ARTG recordPublic respirator, single-use
Australia TGA ARTG Registered Device · Ultra Health Medical Pty Ltd · Suzhou Fangtian Industries Co Ltd · Class I · Started May 06, 2020
Good Name: Ultra Health Medical Pty Ltd - Public respirator, single-use
- Risk Class
- Class I
- Product Type
- Single Device Product
- ARTG Category
- General
- Start Date
- May 06, 2020
- Effective Date
- May 06, 2020
- Country
- China
- Address
- Xiehe Building No 158 Jinmen Road, Suzhou City, Jiangsu
A filtering mask [N95 (filter efficiency 95%)] designed to be placed over the nose and mouth of a member of the general public to permit normal breathing while protecting the wearer from exposure to pathogenic biological airborne particulates during a public health medical emergency (e.g., influenza pandemic). It is typically made of 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.
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 Ultra Health Medical Pty Ltd, manufactured by Suzhou Fangtian Industries Co Ltd in China. The device registration started on May 06, 2020.
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.