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Gown, operating room, single use - ARTG 404463

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 404463 and sponsored by Sentry Medical Pty Ltd, manufactured by Sino Protection (Hefei) Medical Products Co Ltd in China. The device registration started on February 07, 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 Is
ARTG 404463
Class Is
Gown, operating room, single use
ARTG ID: 404463
Good Name: Sentry Medical Pty Ltd - Gown, operating room, single use
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Intended Purpose

It is intended for use during surgical procedures to protect both the patient and operating room personnel from transfer of body fluids and particulate material. This is a single-use device.

Device Classification
Risk Class
Class Is
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
404463
Start Date
February 07, 2023
Effective Date
February 07, 2023
Manufacturer
Country
China
Address
Area B Xinzhan Industrial Park XingHuo road, Hefei, 230011