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Public respirator, single-use - ARTG 335899

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 registered under ARTG number 335899 and 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.

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TGA ARTG Official Data
Class I
ARTG 335899
Class I
Public respirator, single-use
ARTG ID: 335899
Good Name: Ultra Health Medical Pty Ltd - Public respirator, single-use
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Intended Purpose

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.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
335899
Start Date
May 06, 2020
Effective Date
May 06, 2020
Manufacturer
Country
China
Address
Xiehe Building No 158 Jinmen Road, Suzhou City, Jiangsu