Australia TGA ARTG record

Cable/lead, electrocardiograph

Australia TGA ARTG Registered Device · Medtronic Australasia Pty Ltd · Edan Instruments Inc · Class I · Started August 01, 2023

Good Name: Medtronic Australasia Pty Ltd - Cable/lead, electrocardiograph

Device classification

Risk Class: Class I
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: August 01, 2023
Effective Date: August 01, 2023

Sponsor

Name: Medtronic Australasia Pty Ltd

Manufacturer

Name: Edan Instruments Inc
Country: China
Address: #15 Jinhui Road Jinsha Community Kengzi Sub-District Pingshan District, Shenzhen, 518122

Intended purpose

The ECG cable is intended to connect between the patient (through ECG electrodes) to an electrocardiogram medical device to acquire and transfer that medical device the ECG signals.

About this record

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 Medtronic Australasia Pty Ltd, manufactured by Edan Instruments Inc in China. The device registration started on August 01, 2023.

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.