Australia TGA ARTG record

Catheter, urological, Foley

Australia TGA ARTG Registered Device · Key Medical Pty Ltd · Create Medic Co Ltd · Class IIa · Started April 10, 2024

Good Name: Key Medical Pty Ltd - Catheter, urological, Foley

Device classification

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

Registration information

Start Date: April 10, 2024
Effective Date: April 10, 2024

Sponsor

Name: Key Medical Pty Ltd

Manufacturer

Name: Create Medic Co Ltd
Country: Japan
Address: 2-5-25 Chigasakiminami Tsuzuki-Ku, Yokahama, Kanagawa

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

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 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.