Pure Global

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 Industree Group, manufactured by Industree Group in Australia. The device registration started on January 11, 2024.

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
Public respirator, single-use
Australia TGA ARTG Registered Device
Good Name: Industree Group - Public respirator, single-use
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Intended Purpose

A filtering AS/NZS 1716:2012 and AS 4381:2015 Level 3, BSI certified single-use face mask. Non-Sterile face mask for public use with filter efficiency greater than 94%, designed to be placed over the nose and mouth of a member of the general public to protect the wearer from large and small particles when considered necessary (e.g., viral epidemic, fluid resistance). It is typically made of multiple layers of non-woven polymers to produce a soft, flexible mask that will create a seal against the user's face and typically secured using elastic head loops; it may incorporate a forming nose piece (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 11, 2024
Effective Date
January 11, 2024
Sponsor
Manufacturer
Country
Australia
Address
3 Blade Close, Berkeley Vale, NSW, 2261