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Gown, isolation, single use - ARTG 449810

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 registered under ARTG number 449810 and sponsored by VITRYL AUS PTY LTD, manufactured by Unimax Medical Products Co Ltd in China. The device registration started on May 28, 2024.

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 449810
Class I
Gown, isolation, single use
ARTG ID: 449810
Good Name: VITRYL AUS PTY LTD - Gown, isolation, single use
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Intended Purpose

This is a body worn device that has multiple purposes. The device is worn by a healthcare provider as a coverall gown that is intended to be used to protect the wearer from contamination whilst conducting an examination or treatment of a patient and or a visitor or associated persons to isolate them from the patient.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
449810
Start Date
May 28, 2024
Effective Date
May 28, 2024
Manufacturer
Country
China
Address
No 1 Liansai Road Changshangkou Town, Xiantao City, Hubei Provence, 433024