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Mask, surgical, single use - ARTG 339908

Access comprehensive regulatory information for Mask, surgical, 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 339908 and sponsored by Pro-Tek Plastics Australia, manufactured by Crown Name (WH) United Co Ltd in China. The device registration started on July 21, 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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TGA ARTG Official Data
Class I
ARTG 339908
Class I
Mask, surgical, single use
ARTG ID: 339908
Good Name: Pro-Tek Plastics Australia - Mask, surgical, single use
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Intended Purpose

A single use device made from non woven fabrics which is placed over the nose and mouth by medical personnel to prevent the transmission of air borne organisms while surgery is being performed.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
339908
Start Date
July 21, 2020
Effective Date
July 21, 2020
Manufacturer
Country
China
Address
Changhang Building RM 1805 No 69 Yanjiang Avenue, Wuhan, Hubei, 430021