Australia TGA ARTG record

Bladder volume ultrasound imaging system

Australia TGA ARTG Registered Device · Whiteley Diagnostic Pty Ltd · Xuzhou Kaixin Electronic Instrument Co Ltd · Class IIa · Started April 11, 2024

Good Name: Whiteley Diagnostic Pty Ltd - Bladder volume ultrasound imaging system

Device classification

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

Registration information

Start Date: April 11, 2024
Effective Date: April 11, 2024

Sponsor

Name: Whiteley Diagnostic Pty Ltd

Manufacturer

Name: Xuzhou Kaixin Electronic Instrument Co Ltd
Country: China
Address: Kaixin Mansion C-01 Economic Development Zone, Xuzhou, Jiangsu, 221004

Intended purpose

Bladder Scanner is a portable 3D Ultrasound instrument capable of measuring the bladder volume and provide diagnostic data for common urological conditions.

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 sponsored by Whiteley Diagnostic Pty Ltd, manufactured by Xuzhou Kaixin Electronic Instrument Co Ltd in China. The device registration started on April 11, 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.