Australia TGA ARTG record

Catheter, urological, Foley

Australia TGA ARTG Registered Device · Endotherapeutics Pty Ltd · Yushin Medical Co Ltd · Class IIa · Started October 19, 2018

Good Name: Endotherapeutics Pty Ltd - Catheter, urological, Foley

Device classification

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

Registration information

Start Date: October 19, 2018
Effective Date: October 19, 2018

Sponsor

Name: Endotherapeutics Pty Ltd

Manufacturer

Name: Yushin Medical Co Ltd
Country: South Korea
Address: 36 Jomaru-ro 427beon-gil Wonmi-gu, Bucheon-si, Gyeonggi-do, 14558

Intended purpose

Foley catheter with an inflatable balloon on its distal tip for retention in the urinary bladder intended to facilitate urine drainage.

About this record

Access comprehensive regulatory information for Catheter, urological, Foley in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Endotherapeutics Pty Ltd, manufactured by Yushin Medical Co Ltd in South Korea. The device registration started on October 19, 2018.

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.