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Public respirator, single-use - ARTG 341927

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 341927 and sponsored by Strapit Medical and Sports Supplies Pty Ltd, manufactured by Suzhou Fangtian Industries Co Ltd in China. The device registration started on August 21, 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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Class I
ARTG 341927
Class I
Public respirator, single-use
ARTG ID: 341927
Good Name: Strapit Medical and Sports Supplies Pty Ltd - Public respirator, single-use
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Intended Purpose

A non-sterile N95 mask designed to be placed over the nose and mouth of a healthcare and frontline worker to permit normal breathing while protecting the worker and patients from the transfer of airborne particulate materials during medical, surgical, dental, and isolation procedures - incorporates a forming nosepiece (metal wire); it is 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
341927
Start Date
August 21, 2020
Effective Date
August 21, 2020
Manufacturer
Country
China
Address
Xiehe Building No 158 Jinmen Road, Suzhou City, Jiangsu