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Catheter, urological, Foley

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 Dalian Create Medical Products Co Ltd in China. The device registration started on July 02, 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.

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TGA ARTG Official Data
Class IIa
Class IIa
Catheter, urological, Foley
Australia TGA ARTG Registered Device
Good Name: Key Medical Pty Ltd - Catheter, urological, Foley
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Intended Purpose

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

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
July 02, 2018
Effective Date
July 02, 2018
Sponsor
Manufacturer
Country
China
Address
No IIB-31 Dalian Exp Processing Zone, Dalian, Liaoning Province, 116600