Australia TGA ARTG record

Youkey Ultrasound System - Ultrasound system, imaging, general-purpose

Australia TGA ARTG Registered Device · Import Health Pty Ltd · Wuhan Youkey Bio-Medical Electronics Co Ltd · Class IIa · Started March 23, 2022

Good Name: Import Health Pty Ltd - Youkey Ultrasound System - Ultrasound system, imaging, general-purpose

Device classification

Risk Class: Class IIa
Product Type: Medical device system
ARTG Category: General

Registration information

Start Date: March 23, 2022
Effective Date: March 23, 2022

Sponsor

Name: Import Health Pty Ltd

Manufacturer

Name: Wuhan Youkey Bio-Medical Electronics Co Ltd
Country: China
Address: 2nd Floor Dingxin Industry Park Jiayuan Road East Lake Development Zone, Wuhan, 430074

Intended purpose

This device is intended for use by a qualified physician for ultrasound evaluation. Specific clinical applications and exam types include: Abdominal, Obstetrics, Gynaecology, Small Parts (breast, thyroid, etc), Peripheral Vascular, Urology.

About this record

Access comprehensive regulatory information for Youkey Ultrasound System - 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 Import Health Pty Ltd, manufactured by Wuhan Youkey Bio-Medical Electronics Co Ltd in China. The device registration started on March 23, 2022.

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.