Australia TGA ARTG record

Ultrasound system, imaging, general-purpose

Australia TGA ARTG Registered Device · Zone Medical Pty Ltd · Edan Instruments Inc · Class I · Started July 05, 2023

Good Name: Zone Medical Pty Ltd - Ultrasound system, imaging, general-purpose

Device classification

Risk Class: Class I
Product Type: Single Device Product
ARTG Category: General-Export

Registration information

Start Date: July 05, 2023
Effective Date: July 05, 2023

Sponsor

Name: Zone Medical Pty Ltd

Manufacturer

Name: Edan Instruments Inc
Country: China
Address: #15 Jinhui Road Jinsha Community Kengzi Sub-District Pingshan District, Shenzhen, 518122

Intended purpose

The DUS 60 Digital Ultrasonic Diagnostic Imaging System is intended for diagnostic ultrasound imaging analysis in gynecology rooms, obstetrics rooms, examination rooms, intensive care units, and emergency rooms. The DUS 60 is intended for use by or on the order of a physician or similarly qualified health care professional for ultrasound evaluation of Fetus; Abdomen; Pediatrics; Small Organ; Neonatal head; Cardiology; Peripheral Vessel; Musculo-skeleton (both Conventional and Superficial); Urology (including prostate); Transrecta and Transvagina.

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 I is sponsored by Zone Medical Pty Ltd, manufactured by Edan Instruments Inc in China. The device registration started on July 05, 2023.

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.