Australia flagARTG 299569

Bladder volume ultrasound imaging system

ARTG ID: 299569 · Zone Medical Pty Ltd · Xuzhou Kaixin Electronic Instrument Co Ltd · Class IIa · Started February 12, 2018

Good Name: Zone Medical Pty Ltd - Bladder volume ultrasound imaging system

Device classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration information
ARTG ID
299569
Start Date
February 12, 2018
Effective Date
February 12, 2018
Sponsor
Manufacturer
Country
China
Address
Kaixin Mansion C-01 Economic Development Zone, Xuzhou, Jiangsu, 221004
Intended purpose

The Bladder scanner is a portable 3D ultrasound instrument, capable of measuring the bladder volume. They provide accurate data to aid in the diagnosis of common urological conditions, to assess urinary retention, to help prevent unnecessary catheterization, and to reduce rates of catheter-associated urinary tract infection.

About this record

Access comprehensive regulatory information for Bladder volume ultrasound imaging system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 299569 and sponsored by Zone Medical Pty Ltd, manufactured by Xuzhou Kaixin Electronic Instrument Co Ltd in China. The device registration started on February 12, 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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