Australia TGA ARTG record

Surgical/medical respirator, single-use

Australia TGA ARTG Registered Device · Mediflex Industries Pty Ltd · Rizhao Sanqi Medical & Health Articles Co Ltd · Class I · Started May 20, 2022

Good Name: Mediflex Industries 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: May 20, 2022
Effective Date: May 20, 2022

Sponsor

Name: Mediflex Industries Pty Ltd

Manufacturer

Name: Rizhao Sanqi Medical & Health Articles Co Ltd
Country: China
Address: Heshan International Industrial Park Donggang District, Rizhao City, Shandong Province, 276800

Intended purpose

A disposable device made from fabric or other material placed over the nose and mouth by medical personnel to prevent the transmission of airborne organisms while surgery is being performed.

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 Mediflex Industries Pty Ltd, manufactured by Rizhao Sanqi Medical & Health Articles Co Ltd in China. The device registration started on May 20, 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.