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Non-rechargeable semi-automatic external defibrillator - ARTG 209076

Access comprehensive regulatory information for Non-rechargeable semi-automatic external defibrillator in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 209076 and sponsored by APL Group Pty Ltd, manufactured by Mediana Co Ltd in South Korea. The device registration started on May 03, 2013.

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 IIb
ARTG 209076
Class IIb
Non-rechargeable semi-automatic external defibrillator
ARTG ID: 209076
Good Name: APL Group Pty Ltd - Non-rechargeable semi-automatic external defibrillator
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Intended Purpose

To analyse an electrocardiogram, determine whether or not a defibrillator shock should be delivered, and then if required, deliver a defibrillator shock at the operator's command.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
209076
Start Date
May 03, 2013
Effective Date
May 03, 2013
Manufacturer
Country
South Korea
Address
132 Donghwagongdan-ro Munmak-eup Wonju-si, Gangwon-do