Australia TGA ARTG record

Mask, surgical, single use

Australia TGA ARTG Registered Device · SNE International Pty Ltd · DANAMECO MEDICAL JOINT STOCK CORPORATION · Class Is · Started July 29, 2021

Good Name: SNE International Pty Ltd - Mask, surgical, single use

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

Sponsor

Name: SNE International Pty Ltd

Manufacturer

Name: DANAMECO MEDICAL JOINT STOCK CORPORATION
Country: Vietnam
Address: No 12 Trinh Cong Son Street, Hai Chau District, Da Nang City

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.

About this record

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.