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Public respirator, single-use - ARTG 341862

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 341862 and sponsored by Sleepcraft Distributors Pty Ltd, manufactured by Suzhou Fangtian Industries Co Ltd in China. The device registration started on August 20, 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 341862
Class I
Public respirator, single-use
ARTG ID: 341862
Good Name: Sleepcraft Distributors Pty Ltd - Public respirator, single-use
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Intended Purpose

N95 Particulate Disposable Respirator has been designed specifically for the use in a healthcare setting. While delivering the appropriate amount of filtration efficiency against airborne contaminants, it helps provide a larger breathing chamber with no restriction of downward vision, allowing total facial closure for custom fit on any size face when donned correctly. This respirator may also help reduce breathing in some pathogenic biological airborne particulates, but does not eliminate the risk of infection or disease.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
341862
Start Date
August 20, 2020
Effective Date
August 20, 2020
Manufacturer
Country
China
Address
Xiehe Building No 158 Jinmen Road, Suzhou City, Jiangsu