Australia TGA ARTG record

Public respirator, single-use

Australia TGA ARTG Registered Device · Pharma Soul Holdings Pty Ltd · Dongguan Leihuo Medical Device Co Ltd · Class I · Started July 24, 2020

Good Name: Pharma Soul Holdings Pty Ltd - Public respirator, single-use

Device classification

Risk Class: Class I
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: July 24, 2020
Effective Date: July 24, 2020

Sponsor

Name: Pharma Soul Holdings Pty Ltd

Manufacturer

Name: Dongguan Leihuo Medical Device Co Ltd
Country: China
Address: Dongshan Yongshenglu NO 47 Room 101 Qishi, Dongguan, Guangdong

Intended purpose

A disposable device made from fabric or other material placed over the nose and mouth by medical or non-medical personnel to prevent the transmission of airborne organisms.

About this record

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 Pharma Soul Holdings Pty Ltd, manufactured by Dongguan Leihuo Medical Device Co Ltd in China. The device registration started on July 24, 2020.

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.