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Electrode, electrocardiograph, single use - ARTG 380369

Access comprehensive regulatory information for Electrode, electrocardiograph, single use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 380369 and sponsored by Philips Electronics Australia Ltd, manufactured by Philips Medical Systems in United States of America. The device registration started on December 07, 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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TGA ARTG Official Data
Class I
ARTG 380369
Class I
Electrode, electrocardiograph, single use
ARTG ID: 380369
Good Name: Philips Electronics Australia Ltd - Electrode, electrocardiograph, single use
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Intended Purpose

The single use attachment electrode is intended to be an accessory to Fetal Spiral Electrode, for patients requiring fetal heart rate monitoring during labor.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
380369
Start Date
December 07, 2021
Effective Date
December 07, 2021
Manufacturer
Country
United States of America
Address
3000 Minuteman Road, Andover, Massachusetts, 01810-1099