Pure Global

Rechargeable professional automated external defibrillator - ARTG 461487

Access comprehensive regulatory information for Rechargeable professional automated external defibrillator in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 461487 and sponsored by Philips Electronics Australia Ltd, manufactured by Philips Medical Systems in United States of America. The device registration started on August 30, 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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class I
ARTG 461487
Class I
Rechargeable professional automated external defibrillator
ARTG ID: 461487
Good Name: Philips Electronics Australia Ltd - Rechargeable professional automated external defibrillator
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

Device is for use only with the HeartStart FR3 Defibrillator (โ€œFR3โ€) to treat a suspected victim of sudden cardiac arrest who is under 55 lbs (25 kg) or 0-8 years old.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
461487
Start Date
August 30, 2024
Effective Date
August 30, 2024
Manufacturer
Country
United States of America
Address
22100 Bothell Everett Highway, Bothell, WA, 98021