Australia TGA ARTG recordGel, ultrasonic coupling
Australia TGA ARTG Registered Device · Health One Pty Ltd · Nantong Health & Beyond Hygienic Products Inc · Class I · Started November 10, 2022
Good Name: Health One Pty Ltd - Gel, ultrasonic coupling
- Risk Class
- Class I
- Product Type
- Single Device Product
- ARTG Category
- General
- Start Date
- November 10, 2022
- Effective Date
- November 10, 2022
- Country
- China
- Address
- No 118 Yuxian Road North town Street Rugao City, JiangSu Province, 226575
A non-sterile medium designed to be applied to a patient's unbroken skin surface to provide a coupling between an analytical device (e.g., ultrasound transducer, optical glucose monitoring system) and the patient, allowing for the emission and reception of signals (e.g., ultrasound, light) that pass through the skin during an examination. It is in the form of a non-sticky, fluid-like gel that may also assists the operator's ability to move the analytical device smoothly over the skin to better analyse the site of interest. It may be used by a healthcare professional or layperson. After application, this device cannot be reused.
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 Health One Pty Ltd, manufactured by Nantong Health & Beyond Hygienic Products Inc in China. The device registration started on November 10, 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.