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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 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.

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TGA ARTG Official Data
Class I
Class I
Surgical/medical respirator, single-use
Australia TGA ARTG Registered Device
Good Name: Mediflex Industries Pty Ltd - Surgical/medical respirator, single-use
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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.

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