Australia TGA ARTG record

Cardioline WalkFree Holter Monitor - Electrocardiograph, Holter analyser

Australia TGA ARTG Registered Device · Stark Medical · Livetec Ingenieurburo GmbH · Class IIa · Started February 02, 2023

Good Name: Stark Medical - Cardioline WalkFree Holter Monitor - Electrocardiograph, Holter analyser

Device classification

Risk Class: Class IIa
Product Type: Medical device system
ARTG Category: General

Registration information

Start Date: February 02, 2023
Effective Date: February 02, 2023

Sponsor

Name: Stark Medical

Manufacturer

Name: Livetec Ingenieurburo GmbH
Country: Germany
Address: 8 Marie-Curie-Strasse, Lorrach, 79539

Intended purpose

ECG Holter recorder intended for continuous measurement and digital storage of ECG signals during the patient’s daily activities as part of a long‐term Holter ECG. The recorded data are used to diagnose cardiac arrhythmias. The device is indicated for use on adult and paediatric patients.

About this record

Access comprehensive regulatory information for Cardioline WalkFree Holter Monitor - Electrocardiograph, Holter analyser in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Stark Medical, manufactured by Livetec Ingenieurburo GmbH in Germany. The device registration started on February 02, 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.