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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 COWISE GROUP PTY LTD, manufactured by Chengde Technology Co Ltd in China. The device registration started on August 03, 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
Class I
Public respirator, single-use
Australia TGA ARTG Registered Device
Good Name: COWISE GROUP PTY LTD - Public respirator, single-use
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Intended Purpose

A non-sterile folding protective mask KN95 designed to be placed over the nose and mouth to protect from particulates. This respirator may also help reduce breathing in some pathogenic biological airborne particulates, but does not eliminate the risk of infection or disease. This is a single-use device.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
August 03, 2020
Effective Date
August 03, 2020
Manufacturer
Country
China
Address
No 888-1088 Shiji Avenue Longgang City, Zhejiang Province