Australia flagARTG 378297

Ultrasound system, imaging, general-purpose

ARTG ID: 378297 · Fujifilm Australia Pty Ltd · FUJIFILM Healthcare Corporation · Class IIa · Started November 19, 2021

Good Name: Fujifilm Australia Pty Ltd - Ultrasound system, imaging, general-purpose

Device classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration information
ARTG ID
378297
Start Date
November 19, 2021
Effective Date
November 19, 2021
Sponsor
Manufacturer
Country
Japan
Address
2-1 Shintoyofuta Kashiwa-shi, Chiba, 277-0804
Intended purpose

The subject Ultrasound imaging systems are intended for performing tomography and hemodynamic diagnosis of blood flow in the human body. The subject systems are intended to be used by doctors and other qualified health care professionals only.

About this record

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 378297 and sponsored by Fujifilm Australia Pty Ltd, manufactured by FUJIFILM Healthcare Corporation in Japan. The device registration started on November 19, 2021.

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.

Free DatabasePowered by Pure Global AITGA ARTG Official Data