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Analytical non-scalp cutaneous electrode - ARTG 443093

Access comprehensive regulatory information for Analytical non-scalp cutaneous electrode in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 443093 and sponsored by AMBU Australia Pty Ltd, manufactured by Ambu AS in Denmark. The device registration started on March 04, 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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Class I
ARTG 443093
Class I
Analytical non-scalp cutaneous electrode
ARTG ID: 443093
Good Name: AMBU Australia Pty Ltd - Analytical non-scalp cutaneous electrode
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Intended Purpose

A surface electrode intended to be attached to the skin surface of a patient outside of the hair line to conduct electrical signals to a parent device for electrophysiological recording/monitoring.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
443093
Start Date
March 04, 2024
Effective Date
March 04, 2024
Manufacturer
Country
Denmark
Address
Baltorpbakken 13, Ballerup, DK-2750