ARTG 480528

Gown, operating room, single use

ARTG ID: 480528 · Quest Surgical Pty Ltd · Leboo Healthcare Products Ltd · Class Is · Started February 24, 2025

Good Name: Quest Surgical Pty Ltd - Gown, operating room, 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

Sponsor

Name: Quest Surgical Pty Ltd

Manufacturer

Name: Leboo Healthcare Products Ltd
Country: China
Address: A-1506 Lar Valley International No 168 Guang'anmen Wai Street, Xicheng District, Beijing, 100055

Intended purpose

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

About this record

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.