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

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.

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Class IIa
Class IIa
Youkey Ultrasound System - Ultrasound system, imaging, general-purpose
Australia TGA ARTG Registered Device
Good Name: Import Health Pty Ltd - Youkey Ultrasound System - Ultrasound system, imaging, general-purpose
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DJ Fang

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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.

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
Manufacturer
Country
China
Address
2nd Floor Dingxin Industry Park Jiayuan Road East Lake Development Zone, Wuhan, 430074