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 A R Medicom Australia Pty Ltd, manufactured by AMD Ritmed Inc (Canada) in Canada. The device registration started on September 06, 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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TGA ARTG Official Data
Class I
Class I
Surgical/medical respirator, single-use
Australia TGA ARTG Registered Device
Good Name: A R Medicom Australia Pty Ltd - Surgical/medical respirator, single-use
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Intended Purpose

A form-shaped filtering mask designed to be placed over the nose and mouth of a healthcare worker to permit normal breathing while protecting the wearer and patient from large particles (e.g., blood, body fluids, and airborne particulate materials) and small particles (e.g., bacteria and viruses) during medical, surgical, dental, and isolation procedures.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
September 06, 2022
Effective Date
September 06, 2022
Manufacturer
Country
Canada
Address
1200 / 55th Avenue, Lachine, Quebec, H8T3J8