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Catheter, urological, condom - ARTG 449534

Access comprehensive regulatory information for Catheter, urological, condom in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class Is is registered under ARTG number 449534 and sponsored by Livingstone International Pty Ltd, manufactured by GCMedica Enterprise Ltd Wuxi in China. The device registration started on May 23, 2024.

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 449534
Class Is
Catheter, urological, condom
ARTG ID: 449534
Good Name: Livingstone International Pty Ltd - Catheter, urological, condom
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Intended Purpose

This is a body worn device that is intended to be used for male incontinence. This device facilitates the collection of urine via a flexible tube and sheath like device. The body worn device is retained on the penis to lead urine via a tube to a collection bag.

Device Classification
Risk Class
Class Is
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
449534
Start Date
May 23, 2024
Effective Date
May 23, 2024
Manufacturer
Country
China
Address
Loujin Industrial Park Shuofang Wuxi, Jiangsu, 214143