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Gel, ultrasonic coupling

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 Cardiac and Ultrasound Equipment, manufactured by Shanghai Shenfeng Medical & Health Articles Co Ltd in China. The device registration started on February 27, 2023.

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 I
Class I
Gel, ultrasonic coupling
Australia TGA ARTG Registered Device
Good Name: Cardiac and Ultrasound Equipment - Gel, ultrasonic coupling
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Intended Purpose

A medium designed to be applied to a patient's unbroken skin surface (excludes the eye surface) to provide a coupling between an analytical or therapeutic device (e.g., ultrasound transducer, optical glucose monitoring system, transcutaneous electrical stimulator) and the patient, allowing for the emission and reception of energy/signals (e.g., electrical current, light) that pass through the skin during an examination or treatment.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
February 27, 2023
Effective Date
February 27, 2023
Manufacturer
Country
China
Address
159 Pengfeng Road Malu, Jiading Shanghai, 201801