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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 Radiometer Pacific Pty Ltd, manufactured by Radiometer Medical APS in Denmark. The device registration started on November 18, 2021.

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: Radiometer Pacific Pty Ltd - Gel, ultrasonic coupling
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Intended Purpose

Contact gel which is applied to the fixation accessories to establish contact between the skin and the electrode during in vivo measurements.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
November 18, 2021
Effective Date
November 18, 2021
Manufacturer
Country
Denmark
Address
Akandevej 21, Bronshoj, Denmark, 2700