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Gown, operating room, single use

Access comprehensive regulatory information for Gown, operating room, 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 19, 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
Gown, operating room, single use
Australia TGA ARTG Registered Device
Good Name: SNE International Pty Ltd - Gown, operating room, single use
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Intended Purpose

A disposable personal protective garment used in health care settings, it is designed to be worn by surgeons, physicians or the patient to protect them from the transfer of microorganisms, body fluids and particulate matters. It is also used to protect the wearer from the spread of infection or illness if the wearer comes in contact with potentially infectious liquid and solid materials. This is a single-use device and suitable for isolation also.

Device Classification
Risk Class
Class Is
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
July 19, 2021
Effective Date
July 19, 2021
Manufacturer
Country
Vietnam
Address
No 12 Trinh Cong Son Street, Hai Chau District, Da Nang City