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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 SNE International Pty Ltd, manufactured by DANAMECO MEDICAL JOINT STOCK CORPORATION in Vietnam. The device registration started on July 29, 2021.

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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Class Is
Class Is
Mask, surgical, single use
Australia TGA ARTG Registered Device
Good Name: SNE International Pty Ltd - Mask, surgical, single use
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Intended Purpose

A flexible, loose-fitting medical device designed to be placed over the mouth and/or nose to permit normal breathing while protecting the wearer from the transfer of potential contaminants or large particles (e.g., blood, body fluids, and airborne particulate materials) from the environment. It is secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire). This is a single-use device and suitable to be used in surgery or isolation.

Device Classification
Risk Class
Class Is
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
July 29, 2021
Effective Date
July 29, 2021
Manufacturer
Country
Vietnam
Address
No 12 Trinh Cong Son Street, Hai Chau District, Da Nang City