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Mask, surgical, single use

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 sponsored by Paul Hartmann Pty Ltd, manufactured by Zhende Medical Co Ltd in China. The device registration started on August 28, 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
Class I
Mask, surgical, single use
Australia TGA ARTG Registered Device
Good Name: Paul Hartmann Pty Ltd - Mask, surgical, single use
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Intended Purpose

Medical Mask is intended to cover the user’s nose and mouth and provide a physical barrier to fluids and particulate materials.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
August 28, 2020
Effective Date
August 28, 2020
Sponsor
Manufacturer
Country
China
Address
Gaobu Town, Shaoxing, Zhejiang, 312035