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Gown, operating room, single use - ARTG 480528

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 480528 and sponsored by Quest Surgical Pty Ltd, manufactured by Leboo Healthcare Products Ltd in China. The device registration started on February 24, 2025.

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 480528
Class Is
Gown, operating room, single use
ARTG ID: 480528
Good Name: Quest Surgical Pty Ltd - Gown, operating room, single use
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Intended Purpose

This is a sterile surgical gown used in the operating theatres and day procedures. Single Use.

Device Classification
Risk Class
Class Is
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
480528
Start Date
February 24, 2025
Effective Date
February 24, 2025
Manufacturer
Country
China
Address
A-1506 Lar Valley International No 168 Guang'anmen Wai Street, Xicheng District, Beijing, 100055