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Surgical/medical respirator, single-use

Australia TGA ARTG Registered Device · Lohas Holding Pty Ltd · 3A Medical Products Co Ltd · Class I · Started June 21, 2022

Good Name: Lohas Holding Pty Ltd - Surgical/medical respirator, single-use

Device classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration information
Start Date
June 21, 2022
Effective Date
June 21, 2022
Sponsor
Manufacturer
Country
China
Address
Yu An Industrial Park, Liu An, 230001
Intended purpose

A non-sterile filtering mask designed to be placed over the nose and mouth of a healthcare worker to permit normal breathing while protecting the worker and patients from the transfer of microorganisms, blood, body fluids, and airborne particulate materials during medical, surgical, dental, and isolation procedures. It is typically made of multiple layers of non-woven polymers, and incorporates a forming nosepiece (metal wire); it is typically secured using elastic head straps. This is a single-use device.

About this record

Access comprehensive regulatory information for Surgical/medical respirator, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Lohas Holding Pty Ltd, manufactured by 3A Medical Products Co Ltd in China. The device registration started on June 21, 2022.

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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