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Electrode, electrocardiograph, single use - ARTG 277069

Access comprehensive regulatory information for Electrode, electrocardiograph, single use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 277069 and sponsored by Innovative Medical Solutions, manufactured by Bio Protech Inc in South Korea. The device registration started on June 27, 2016.

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 277069
Class I
Electrode, electrocardiograph, single use
ARTG ID: 277069
Good Name: Innovative Medical Solutions - Electrode, electrocardiograph, single use
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Intended Purpose

A single use device that attaches to a patient via adhesive and detects heart signal which are then transferred by a lead to the ECG recorder.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
277069
Start Date
June 27, 2016
Effective Date
June 27, 2016
Sponsor
Manufacturer
Country
South Korea
Address
Donghwa Medical Instrument complex 151-3 Donghwagongdan-ro Munmak-eup, Wonju-si, Gangwon-do