Pure Global

Surgical/medical respirator, single-use - ARTG 389571

Access comprehensive regulatory information for Surgical/medical respirator, 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 389571 and sponsored by Wiselink Group Pty Ltd, manufactured by Rizhao Sanqi Medical & Health Articles Co Ltd in China. The device registration started on June 03, 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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TGA ARTG Official Data
Class I
ARTG 389571
Class I
Surgical/medical respirator, single-use
ARTG ID: 389571
Good Name: Wiselink Group Pty Ltd - Surgical/medical respirator, single-use
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Intended Purpose

This filtering half-mask is a respiratory protection equipment and is suitable for filtrating contaminants in aerosols and provides fluid penetration resistance.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
389571
Start Date
June 03, 2022
Effective Date
June 03, 2022
Manufacturer
Country
China
Address
Heshan International Industrial Park Donggang District, Rizhao City, Shandong Province, 276800