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Surgical/medical respirator, single-use - ARTG 480945

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 480945 and sponsored by Chem-Pack Supplies Australasia Pty Ltd, manufactured by Iconic Medicare Sdn Bhd in Malaysia. The device registration started on February 26, 2025.

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 480945
Class I
Surgical/medical respirator, single-use
ARTG ID: 480945
Good Name: Chem-Pack Supplies Australasia Pty Ltd - Surgical/medical respirator, single-use
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Intended Purpose

The non-sterile Surgical respirator is intended for use by healthcare workers and public users to protect against transfer of microorganisms, Blood, Bodily fluids and airborne particulates.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
480945
Start Date
February 26, 2025
Effective Date
February 26, 2025
Manufacturer
Country
Malaysia
Address
PMT 798 Lingkaran Cassia Selatan Taman Perindustrian Batu Kawan, Bandar Cassia, Penang, 14110