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Ultrasound system, imaging, general-purpose - ARTG 472187

Access comprehensive regulatory information for Ultrasound system, imaging, general-purpose in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 472187 and sponsored by Simie Holdings Pty Ltd as trustee for Simie Business Trust trading as New Wave Medical WA, manufactured by Shenzhen Mindray Bio Medical Electronics Co Ltd in China. The device registration started on December 09, 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 472187
Class IIa
Ultrasound system, imaging, general-purpose
ARTG ID: 472187
Good Name: Simie Holdings Pty Ltd as trustee for Simie Business Trust trading as New Wave Medical WA - Ultrasound system, imaging, general-purpose
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Intended Purpose

A range of general-purpose diagnostic ultrasound imaging systems designed exclusively for use in a wide variety of both extracorporeal and/or intracorporeal body imaging procedures. These ultrasound systems support a wide variety of transducers and related software allowing for the collection, display and analysis of ultrasound information. Usages are, e.g. general-purpose imaging, cardiac, OB/GYN, endoscopy, breast, prostate, vascular, intra-surgical, Doppler or colour Doppler. Selection of a transducer and associated software enables these different types of examinations.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
472187
Start Date
December 09, 2024
Effective Date
December 09, 2024
Manufacturer
Country
China
Address
Mindray Building Keji 12th Road South Hi-Tech Industrial Park, Nanshan District, Shenzhen Guangdong, 518057