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Catheter, urological, Foley - ARTG 432170

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 registered under ARTG number 432170 and sponsored by Coloplast Pty Ltd, manufactured by Yushin Medical Co Ltd in South Korea. The device registration started on January 02, 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 IIa
ARTG 432170
Class IIa
Catheter, urological, Foley
ARTG ID: 432170
Good Name: Coloplast Pty Ltd - Catheter, urological, Foley
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Intended Purpose

Silicon Foley Balloon Catheter is used for the patient who is required routine or post-operative urinary drainage and irrigation of the bladder. This sterile catheter should be used by urologist or healthcare professional.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
432170
Start Date
January 02, 2024
Effective Date
January 02, 2024
Manufacturer
Country
South Korea
Address
36 Jomaru-ro 427beon-gil, Bucheon-si, Gyeonggi-do, 14558