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Cable/lead, electrocardiograph

Access comprehensive regulatory information for Cable/lead, electrocardiograph in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is 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
Class I
Cable/lead, electrocardiograph
Australia TGA ARTG Registered Device
Good Name: Philips Electronics Australia Ltd - Cable/lead, electrocardiograph
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Intended Purpose

The DECG Reusable Legplate Adapter Cable (adapter cable) is intended to be an accessory to Fetal Spiral Electrode, for patients requiring fetal heart rate monitoring during labor. These devices are limited by the indications for use of the connected monitor in healthcare facilities.

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