Australia TGA ARTG record

Patient monitor, electrocardiograph

Australia TGA ARTG Registered Device · Cardioscan Services Pty Ltd · Edan Instruments Inc · Class IIa · Started March 20, 2019

Good Name: Cardioscan Services Pty Ltd - Patient monitor, electrocardiograph

Device classification

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

Registration information

Start Date: March 20, 2019
Effective Date: March 20, 2019

Sponsor

Name: Cardioscan Services 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 device is to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However the interpreted ECG with measurements and interpretive statements is offered to clinicians a on an advisory basis only.

About this record

Access comprehensive regulatory information for Patient monitor, electrocardiograph in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Cardioscan Services Pty Ltd, manufactured by Edan Instruments Inc in China. The device registration started on March 20, 2019.

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.