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Bladder volume ultrasound imaging system

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 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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Class IIa
Class IIa
Bladder volume ultrasound imaging system
Australia TGA ARTG Registered Device
Good Name: Zone Medical Pty Ltd - Bladder volume ultrasound imaging system
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DJ Fang

DJ Fang

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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.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
February 12, 2018
Effective Date
February 12, 2018
Manufacturer
Country
China
Address
Kaixin Mansion C-01 Economic Development Zone, Xuzhou, Jiangsu, 221004