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Mask, surgical, single use - ARTG 391674

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 391674 and sponsored by Wiselink Group Pty Ltd, manufactured by Rizhao Sanqi Medical & Health Articles Co Ltd in China. The device registration started on July 01, 2022.

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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Class I
ARTG 391674
Class I
Mask, surgical, single use
ARTG ID: 391674
Good Name: Wiselink Group Pty Ltd - Mask, surgical, single use
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Intended Purpose

A disposable mask used by healthcare professionals that creates a physical barrier between the mouth and nose of the wearer and potential contaminants in the immediate environment. The surgical mask blocks large-particle droplets, splashes, sprays, or splatter that may contain germs (viruses and bacteria), keeping it from reaching the wearerโ€™s mouth and nose. Surgical masks also reduce transmitting the wearerโ€™s saliva and respiratory secretions to others.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
391674
Start Date
July 01, 2022
Effective Date
July 01, 2022
Manufacturer
Country
China
Address
Heshan International Industrial Park Donggang District, Rizhao City, Shandong Province, 276800