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Catheter, urological, Foley - ARTG 398612

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 398612 and sponsored by Health One Pty Ltd, manufactured by Shanghai Kindly Enterprise Development Group Co Ltd in China. The device registration started on October 31, 2022.

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 398612
Class IIa
Catheter, urological, Foley
ARTG ID: 398612
Good Name: Health One Pty Ltd - Catheter, urological, Foley
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Intended Purpose

The catheters are flexible tubes that are passed through the urethra during urinary catheterization and into the bladder to drain urine, or for inserting fluids into the bladder. it is used in departments of urology, internal medicine, surgery, obstetrics, and gynecology for drainage of urine and medication. It is also used for patients suffering from moving with difficulty or being completely bed-ridden.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
398612
Start Date
October 31, 2022
Effective Date
October 31, 2022
Manufacturer
Country
China
Address
No 658 Gaochao Road, Shanghai, 201803