ARTG 477448

Cover, shoe, <specify>

ARTG ID: 477448 · Quest Surgical Pty Ltd · Leboo Healthcare Products Ltd · Class I · Started February 03, 2025

Good Name: Quest Surgical Pty Ltd - Cover, shoe, <specify>

Device classification

Risk Class: Class I
Product Type: Single Device Product
ARTG Category: General

Registration information

ARTG ID: 477448
Start Date: February 03, 2025
Effective Date: February 03, 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

A shoe cover intended to be worn over the shoes of healthcare staff during a surgical procedure to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the patient, environment and staff.

About this record

Access comprehensive regulatory information for Cover, shoe, <specify> in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 477448 and sponsored by Quest Surgical Pty Ltd, manufactured by Leboo Healthcare Products Ltd in China. The device registration started on February 03, 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.