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Interpretive multichannel electrocardiograph - ARTG 454165

Access comprehensive regulatory information for Interpretive multichannel electrocardiograph in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 454165 and sponsored by Intermed Medical Pty Ltd, manufactured by Schiller AG in Switzerland. The device registration started on July 02, 2024.

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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Class IIa
ARTG 454165
Class IIa
Interpretive multichannel electrocardiograph
ARTG ID: 454165
Good Name: Intermed Medical Pty Ltd - Interpretive multichannel electrocardiograph
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Intended Purpose

The CARDIOVIT FT-2 is an electrocardiograph device intended to be used by or under the direct supervision of a licensed physician in healthcare facilities to acquire ECG signals from body surface electrodes, record, analyse, display and print ECGs to support diagnosis in adult and paediatric patients at rest. The spirometry option is intended to record, analyse, display and print measurements and waveforms of pulmonary function tests to support diagnosis in adult and paediatric patients.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
454165
Start Date
July 02, 2024
Effective Date
July 02, 2024
Manufacturer
Country
Switzerland
Address
Altgasse 68, Baar, 6341