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Gown, operating room, single use - ARTG 472145

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 registered under ARTG number 472145 and sponsored by ALMITAS GROUP INTERNATIONAL PTY LTD, manufactured by Dansu-China Health Care Co Ltd in China. The device registration started on December 09, 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 Is
ARTG 472145
Class Is
Gown, operating room, single use
ARTG ID: 472145
Good Name: ALMITAS GROUP INTERNATIONAL PTY LTD - Gown, operating room, single use
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Intended Purpose

A multipurpose garment, made of natural, synthetic or a combination of these materials, worn over scrub suits during surgical procedures. Depending on its intended use, it may be fluid resistant or impervious to fluid. An operating room gown is 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.

Device Classification
Risk Class
Class Is
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
472145
Start Date
December 09, 2024
Effective Date
December 09, 2024
Manufacturer
Country
China
Address
No 2 Hengxin Road Linkong Economic Zone, Xiaogan City, Hubei Province, 432000