Australia TGA ARTG record

Non-rechargeable semi-automatic external defibrillator

Australia TGA ARTG Registered Device · The Trustee for the Taleb Family Trust T/A Taleb Medical and Vetequip Australia · Instramed Industria Medico Hospitalar Ltda · Class IIb · Started July 01, 2022

Good Name: The Trustee for the Taleb Family Trust T/A Taleb Medical and Vetequip Australia - Non-rechargeable semi-automatic external defibrillator

Device classification

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

Registration information

Start Date: July 01, 2022
Effective Date: July 01, 2022

Sponsor

Name: The Trustee for the Taleb Family Trust T/A Taleb Medical and Vetequip Australia

Manufacturer

Name: Instramed Industria Medico Hospitalar Ltda
Country: Brazil
Address: Rua Beco Jose Paris 339 Pavilhao 19, Sarandi, Porto Alegre CEP, 91140-310

Intended purpose

A semi-Automatic External Defibrillator with a Non-rechargeable battery (with an option for a re-chargeable battery) is a portable electronic device designed to monitor and automatically detect cardiac arrhythmias (ventricular fibrillation/pulseless ventricular tachycardia) in a sudden cardiac arrest (SCA) situation. The AED instructs a first responder to commence guided CPR using a compression and frequency monitor and to safely activate defibrillation of the heart through application of electrical shocks to the chest surface when required. The device is placed in a public location and is intended to be applied to the patient by a layperson or trained professional. It consists of an external pulse generator (EPG) with a cardiac rhythm recognition system and a pair of skin-adhesive electrodes and/or optional 3-lead ECG cable to monitor the rhythm and deliver the shocks. The device can be used with adult defibrillation pads or paediatric pads.

About this record

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 sponsored by The Trustee for the Taleb Family Trust T/A Taleb Medical and Vetequip Australia, manufactured by Instramed Industria Medico Hospitalar Ltda in Brazil. The device registration started on July 01, 2022.

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.