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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 Texas Medical Technology (Australia) Pty Ltd, manufactured by Rizhao Sanqi Medical & Health Articles 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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TGA ARTG Official Data
Class I
Class I
Surgical/medical respirator, single-use
Australia TGA ARTG Registered Device
Good Name: Texas Medical Technology (Australia) Pty Ltd - Surgical/medical respirator, single-use
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Intended Purpose

A single-use NIOSH-Approved N95 Particulate Filtering Facepiece Respirators, also used as surgical respirator designed to be placed over the nose and mouth of a member of the medical staff and/or general public to permit normal breathing while protecting the wearer from exposure to pathogenic biological airborne particulates during a public health medical emergency.

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
Manufacturer
Country
China
Address
Heshan International Industrial Park Donggang District, Rizhao City, Shandong Province, 276800