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Extracorporeal ultrasound imaging system transducer, hand-held

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.

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TGA ARTG Official Data
Class IIa
Class IIa
Extracorporeal ultrasound imaging system transducer, hand-held
Australia TGA ARTG Registered Device
Good Name: Fujifilm Australia Pty Ltd - Extracorporeal ultrasound imaging system transducer, hand-held
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Intended Purpose

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

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
Manufacturer
Country
Japan
Address
2-1 Shintoyofuta Kashiwa-shi, Chiba, 277-0804