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Cover, shoe, <specify> - ARTG 477448

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.

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TGA ARTG Official Data
Class I
ARTG 477448
Class I
Cover, shoe, <specify>
ARTG ID: 477448
Good Name: Quest Surgical Pty Ltd - Cover, shoe, <specify>
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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.

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
Manufacturer
Country
China
Address
A-1506 Lar Valley International No 168 Guang'anmen Wai Street, Xicheng District, Beijing, 100055