Pure Global

Gel, ultrasonic coupling - ARTG 211680

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 registered under ARTG number 211680 and 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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class I
ARTG 211680
Class I
Gel, ultrasonic coupling
ARTG ID: 211680
Good Name: Sigma Company Limited - Gel, ultrasonic coupling
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
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.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
211680
Start Date
July 02, 2013
Effective Date
July 02, 2013
Manufacturer
Country
China
Address
159 Pengfeng Road Malu, Jiading Shanghai, 201801