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Public respirator, single-use

Australia TGA ARTG Registered Device · Pharma Soul Holdings Pty Ltd · Makrite Industries Inc. · Class I · Started August 07, 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
August 07, 2020
Effective Date
August 07, 2020
Sponsor
Manufacturer
Country
Taiwan
Address
11F-5 No 79 Sec 1 Xin Tai 5th Road, Xizhi District, New Taipei City
Intended purpose

A non-sterile NIOSH Certified, N95 mask designed to be placed over the nose and mouth of medical or non-medical personnel to permit normal breathing while protecting the worker and patients from the transmission of airborne organisms. This is a single-use device.

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 Makrite Industries Inc. in Taiwan. The device registration started on August 07, 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.

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