Pure Global

Surgical/medical respirator, single-use

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 Livingstone International Pty Ltd, manufactured by Livingstone International Pty Ltd in Australia. The device registration started on January 30, 2023.

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
Class I
Surgical/medical respirator, single-use
Australia TGA ARTG Registered Device
Good Name: Livingstone International Pty Ltd - Surgical/medical respirator, single-use
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Intended Purpose

A non-sterile N95 mask designed to be placed over the nose and mouth to permit normal breathing while protecting the users from the transfer of microorganisms, blood, body fluids, and airborne particulate materials during medical, dental, or other healthcare procedures. It is made of non-woven polymers, and incorporates a forming nosepiece (metal wire) This is a single-use device.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
January 30, 2023
Effective Date
January 30, 2023
Manufacturer
Country
Australia
Address
Suite 1 Level 9 Building 3 189 O'Riordan Street, Mascot, NSW, 2020