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Bladder volume ultrasound imaging system - ARTG 457830

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 457830 and sponsored by Whiteley Diagnostic Pty Ltd, manufactured by Suzhou Peaksonic Medical Technology Co Ltd in China. The device registration started on July 31, 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.

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Class IIa
ARTG 457830
Class IIa
Bladder volume ultrasound imaging system
ARTG ID: 457830
Good Name: Whiteley Diagnostic Pty Ltd - Bladder volume ultrasound imaging system
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DJ Fang

DJ Fang

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Intended Purpose

Hand Held, portable Bladder Scanner is a portable 3D ultrasound instrument capable of measuring the bladder volume and provide diagnostic data for common urological conditions. All in one unit with contains the scanner and display for ease of use.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
457830
Start Date
July 31, 2024
Effective Date
July 31, 2024
Manufacturer
Country
China
Address
2A Building G4 Kunshan Hi-Tech Medical Device Industrial Park Qiandeng Town, Kunshan, Suzhou, Jiangsu, 215341