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Mask, surgical, single use - ARTG 481609

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 registered under ARTG number 481609 and sponsored by Epique Biomedical Solutions Pty Ltd, manufactured by Cross Protection M Sdn Bhd in Malaysia. The device registration started on March 04, 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 481609
Class I
Mask, surgical, single use
ARTG ID: 481609
Good Name: Epique Biomedical Solutions Pty Ltd - Mask, surgical, single use
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Intended Purpose

A single use face mask for use by healthcare workers to permit normal breathing and protect the patient and staff member from the transfer of large particles.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
481609
Start Date
March 04, 2025
Effective Date
March 04, 2025
Manufacturer
Country
Malaysia
Address
No 9 & 11 Jalan Perindustrian 5 Batu 5 1/1 Off Jalan Haji Abdul Manan Jalan Meru, Klang, Selangor Darul Ehsan, 41050