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Gel, ultrasonic coupling - ARTG 465768

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 Is is registered under ARTG number 465768 and sponsored by Imaging Solutions Pty Ltd, manufactured by HR Pharmaceuticals Inc Trade Name: HR Healthcare in United States of America. The device registration started on October 24, 2024.

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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TGA ARTG Official Data
Class Is
ARTG 465768
Class Is
Gel, ultrasonic coupling
ARTG ID: 465768
Good Name: Imaging Solutions Pty Ltd - Gel, ultrasonic coupling
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Intended Purpose

A medium for providing improved contact and conditions for the emission and reception of the ultrasonic waves that pass through the skin during an ultrasound examination. It also assists the operator's ability to move the probe smoothly over the skin.

Device Classification
Risk Class
Class Is
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
465768
Start Date
October 24, 2024
Effective Date
October 24, 2024
Manufacturer
Country
United States of America
Address
3630 Concord Rd, York, PA, 17402