Australia TGA ARTG record

Ultrasound system, imaging, general-purpose

Australia TGA ARTG Registered Device · Whiteley Diagnostic Pty Ltd · Beijing SonopTek Co Ltd · Class IIa · Started August 03, 2016

Good Name: Whiteley Diagnostic Pty Ltd - Ultrasound system, imaging, general-purpose

Device classification

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

Registration information

Start Date: August 03, 2016
Effective Date: August 03, 2016

Sponsor

Name: Whiteley Diagnostic Pty Ltd

Manufacturer

Name: Beijing SonopTek Co Ltd
Country: China
Address: Room 1504 Floor 15 Building 1 No 1 Shangdi 10th Street Haidan District, Beijing, 100085

Intended purpose

Ultrasound Imaging system designed for use in a wide variety of imaging applications and for general imaging including ob/gyn, breast, musculoskeletal, general imaging.

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 Whiteley Diagnostic Pty Ltd, manufactured by Beijing SonopTek Co Ltd in China. The device registration started on August 03, 2016.

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.