Australia TGA ARTG record

Gel, ultrasonic coupling

Australia TGA ARTG Registered Device · Sigma Company Limited · Shanghai Shenfeng Medical & Health Articles Co Ltd · Class I · Started July 02, 2013

Good Name: Sigma Company Limited - Gel, ultrasonic coupling

Device classification

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

Registration information

Start Date: July 02, 2013
Effective Date: July 02, 2013

Sponsor

Name: Sigma Company Limited

Manufacturer

Name: Shanghai Shenfeng Medical & Health Articles Co Ltd
Country: China
Address: 159 Pengfeng Road Malu, Jiading Shanghai, 201801

Intended purpose

This is a gel that is used during an ultrasonic procedure to enable a device to move smoothly with reduced friction over the surface area of skin that is under investigation.

About this record

Access comprehensive regulatory information for Gel, ultrasonic coupling in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Sigma Company Limited, manufactured by Shanghai Shenfeng Medical & Health Articles Co Ltd in China. The device registration started on July 02, 2013.

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.