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Surgical/medical face mask, non-antimicrobial, single-use - ARTG 427653

Access comprehensive regulatory information for Surgical/medical face mask, non-antimicrobial, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 427653 and sponsored by Health One Pty Ltd, manufactured by Guangzhou FuZelong Hygiene Material Co Ltd in China. The device registration started on November 09, 2023.

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
ARTG 427653
Class I
Surgical/medical face mask, non-antimicrobial, single-use
ARTG ID: 427653
Good Name: Health One Pty Ltd - Surgical/medical face mask, non-antimicrobial, single-use
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Intended Purpose

This product is intended to be worn by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids and airbone particulates during surgery or medical examinations.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
427653
Start Date
November 09, 2023
Effective Date
November 09, 2023
Manufacturer
Country
China
Address
12 Guancun Road Jiangpu Street, Conghua Guangzhou City, Guangdong Province, 510900