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Cable/lead, electrocardiograph - ARTG 380945

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 registered under ARTG number 380945 and sponsored by Global Medical Solutions Australia Pty Limited, manufactured by IVY Biomedical Systems Inc in United States of America. The device registration started on December 16, 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 380945
Class I
Cable/lead, electrocardiograph
ARTG ID: 380945
Good Name: Global Medical Solutions Australia Pty Limited - Cable/lead, electrocardiograph
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Intended Purpose

IVY Biomedical radiolucent leadwires are intended for use in X-ray imaging environments, to connect electrodes placed at appropriate sites on the patient to an ECG/EKG device for general monitoring and/or diagnostic evaluation by a healthcare professional.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
380945
Start Date
December 16, 2021
Effective Date
December 16, 2021
Manufacturer
Country
United States of America
Address
11 Business Park Drive, BRANFORD, Connecticut, 06405