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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 Is is sponsored by De La Fontaine Australia Pty Ltd, manufactured by WUYISHAN JIEAN MEDICAL DEVICE MANUFACTURING 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 Is
Class Is
Mask, surgical, single use
Australia TGA ARTG Registered Device
Good Name: De La Fontaine Australia Pty Ltd - Mask, surgical, single use
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Intended Purpose

The manufacturers intended purpose of the Type IIR Sterile Surgical Face Mask is to prevent the transmission of airborne organisms and particulates. It is to be place securely over the nose, mouth and chin with ear loops attached around each ear. Type IIR Sterile Surgical Face Mask is designed for single use only.

Device Classification
Risk Class
Class Is
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
August 05, 2020
Effective Date
August 05, 2020
Manufacturer
Country
China
Address
Xianan Road Ecological Business Park, Wuyishan City, Fujian Province, 354300