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Gown, operating room, single use - ARTG 429557

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 I is registered under ARTG number 429557 and sponsored by Constar X Pty Ltd, manufactured by Feixi Hongwei Medical Devices Co Ltd in China. The device registration started on December 04, 2023.

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 429557
Class I
Gown, operating room, single use
ARTG ID: 429557
Good Name: Constar X Pty Ltd - Gown, operating room, single use
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Intended Purpose

A multipurpose opaque garment, made of trilaminate non woven material. It is fluid resistant used during surgical procedures to protect both the patient and operating room personnel from the transfer of micro-organisms, body fluids and particulate material. This is a disposable garment with waist and neck ties and an open back.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
429557
Start Date
December 04, 2023
Effective Date
December 04, 2023
Manufacturer
Country
China
Address
2F Building 6 Clanggu Road Feixi Country, Hefei City, Auhui Province