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Cable/lead, electrocardiograph - ARTG 398222

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 398222 and sponsored by Tenacore Pty Ltd, manufactured by Shenzhen Med-link Electronics Tech Co Ltd in China. The device registration started on October 24, 2022.

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 398222
Class I
Cable/lead, electrocardiograph
ARTG ID: 398222
Good Name: Tenacore Pty Ltd- Cable/lead, electrocardiograph
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Intended Purpose

A cable used to conduct electrical signals from a patients heart to the surface of chest/limbs via an electrode to an electrocardiograph (ECG) patient monitoring system. . However, the interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
398222
Start Date
October 24, 2022
Effective Date
October 24, 2022
Sponsor
Manufacturer
Country
China
Address
4th and 5th Floor Building Two Hualian Industrial Zone Xinshi Community, Dalang Street, Longhua District, Shenzhen, 518109