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Physiologic-monitoring defibrillation system - ARTG 362650

Access comprehensive regulatory information for Physiologic-monitoring defibrillation system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 362650 and sponsored by Philips Electronics Australia Ltd, manufactured by Schiller AG in Switzerland. The device registration started on April 20, 2021.

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 362650
Class IIb
Physiologic-monitoring defibrillation system
ARTG ID: 362650
Good Name: Philips Electronics Australia Ltd - Physiologic-monitoring defibrillation system
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Intended Purpose

The Tempus LS is a defibrillator that can deliver a shock in automatic, manual or Pacemaker mode with the following feature: CPR Feedback sensor. In addition, the ECG signal of the 3/4-wire ECG patient cable can be display (used normally for the Demand Pacemaker) and can be used for a continuously attended patient ECG signal display (without alarm handling). The device is for use by professional persons who are trained in basic life support (BLS) and defibrillation or advanced cardiac life support (ACLS). The device is intended for single patient use only.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
362650
Start Date
April 20, 2021
Effective Date
April 20, 2021
Manufacturer
Country
Switzerland
Address
Altgasse 68, Baar, 6341