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Gown, isolation, single use

Australia TGA ARTG Registered Device · Niagara Australia Pty Ltd · Phu Tuong Garment Company Limited · Class I · Started June 04, 2020

Good Name: Niagara Australia Pty Ltd - Gown, isolation, single use

Device classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration information
Start Date
June 04, 2020
Effective Date
June 04, 2020
Sponsor
Manufacturer
Country
Vietnam
Address
Nong Son Hamlet Dien Phuoc Commune, Dien Ban Town, Quang Nam
Intended purpose

A multipurpose garment, made of natural, synthetic or a combination of materials, worn by healthcare providers or visitors to isolate them from the patient. The isolation gown protects the patient, e.g. burn patients, from the transfer of infectious agents carried by the healthcare provider or visitor; or it can protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a disposable garment.

About this record

Access comprehensive regulatory information for Gown, isolation, single use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Niagara Australia Pty Ltd, manufactured by Phu Tuong Garment Company Limited in Vietnam. The device registration started on June 04, 2020.

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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