Pure Global

Catheter, urological, Foley - ARTG 445631

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 445631 and sponsored by Key Medical Pty Ltd, manufactured by Create Medic Co Ltd in Japan. The device registration started on April 10, 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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class IIa
ARTG 445631
Class IIa
Catheter, urological, Foley
ARTG ID: 445631
Good Name: Key Medical Pty Ltd - Catheter, urological, Foley
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

Foley catheter with an inflatable balloon on its distal tip for retention in the urinary bladder intended to be used for short term us for urinary incontinence

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
445631
Start Date
April 10, 2024
Effective Date
April 10, 2024
Manufacturer
Country
Japan
Address
2-5-25 Chigasakiminami Tsuzuki-Ku, Yokahama, Kanagawa