Australia TGA ARTG record

Ultrasound system, imaging, general-purpose

Australia TGA ARTG Registered Device · Pentax Medical Singapore Pte Ltd · FUJIFILM Healthcare Corporation · Class IIa · Started November 12, 2021

Good Name: Pentax Medical Singapore Pte Ltd - Ultrasound system, imaging, general-purpose

Device classification

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

Registration information

Start Date: November 12, 2021
Effective Date: November 12, 2021

Sponsor

Name: Pentax Medical Singapore Pte Ltd

Manufacturer

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

Intended purpose

A diagnostic system used to provide various ultrasound images of the body. The system allows for the collection, display and analysis of the ultrasound information

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 sponsored by Pentax Medical Singapore Pte Ltd, manufactured by FUJIFILM Healthcare Corporation in Japan. The device registration started on November 12, 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.