Australia TGA ARTG record

Extracorporeal ultrasound imaging system transducer, hand-held

Australia TGA ARTG Registered Device · Fujifilm Australia Pty Ltd · FUJIFILM Healthcare Corporation · Class IIa · Started November 19, 2021

Good Name: Fujifilm Australia Pty Ltd - Extracorporeal ultrasound imaging system transducer, hand-held

Device classification

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

Registration information

Start Date: November 19, 2021
Effective Date: November 19, 2021

Sponsor

Name: Fujifilm Australia Pty Ltd

Manufacturer

Name: FUJIFILM Healthcare Corporation
Country: Japan
Address: 2-1 Shintoyofuta Kashiwa-shi, Chiba, 277-0804

Intended purpose

The subject hand-held ultrasound imaging transducers are intended to be moved over the intact surface of patient’s body for observation of surrounding organs during general-purpose ultrasound imaging applications.

About this record

Access comprehensive regulatory information for Extracorporeal ultrasound imaging system transducer, hand-held in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is 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.