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Helmet, surgical - ARTG 341287

Access comprehensive regulatory information for Helmet, surgical in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 341287 and sponsored by International Medical Research Pty Ltd, manufactured by Ningbo Luke Medical Devices Co Ltd in China. The device registration started on August 11, 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 341287
Class I
Helmet, surgical
ARTG ID: 341287
Good Name: International Medical Research Pty Ltd - Helmet, surgical
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Intended Purpose

A device intended to protect healthcare workers from contaminants ad debris. It is composed of a helmet frame and a face shield.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
341287
Start Date
August 11, 2020
Effective Date
August 11, 2020
Manufacturer
Country
China
Address
Gujiayan Yangming Road, Yuyao City, Zhejiang Province, 315400