Pure Global

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 Is is sponsored by Wiselink Group Pty Ltd, manufactured by BJZHF Panther Medical Equipment Co Ltd in China. The device registration started on August 14, 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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class Is
Class Is
Mask, surgical, single use
Australia TGA ARTG Registered Device
Good Name: Wiselink Group Pty Ltd - Mask, surgical, single use
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

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

Device Classification
Risk Class
Class Is
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
August 14, 2020
Effective Date
August 14, 2020
Manufacturer
Country
China
Address
Floor 3 Building 1 28 Huoju Street - Changping Science and Technology Park, Changping District, Beijing, 102200