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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 Wiselink Group Pty Ltd, manufactured by BJZHF Panther Medical Equipment Co Ltd in China. The device registration started on August 05, 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: Wiselink Group Pty Ltd - Mask, surgical, single use
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DJ Fang

DJ Fang

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Intended Purpose

Pantherยฎ surgical face mask: Type IIR medical face mask designed in line with European Standard EN 14683:2019 to be placed over the nose and mouth to prevent the transmission of airborne organisms during surgery or patient examination; this is a disposable, non sterile device.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
August 05, 2020
Effective Date
August 05, 2020
Manufacturer
Country
China
Address
Floor 3 Building 1 28 Huoju Street - Changping Science and Technology Park, Changping District, Beijing, 102200