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Schiller Tempus LS Defibrillator - HSA Registration DE0504069

Access comprehensive regulatory information for Schiller Tempus LS Defibrillator in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0504069 and owned by SCHILLER AG. The device was registered on January 24, 2020.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS C
DE0504069
Schiller Tempus LS Defibrillator
HSA Registration Number: DE0504069
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Product Description

The Tempus LS is a defibrillator that can deliver a shock in automatic, manual or Pacemaker mode. The device can be used for patient monitoring without alarms and with the following optional features: • 3-wire and 4-wire ECG cable (without alarm handling) • SpO2 sensor (without alarm handling). The therapeutic indications are: • Manual – manual defibrillation will be indicated for pulseless, unconscious, not breathing patients with VF or VT. • AED will be indicated for VF and rapid/fine VT. • Cardioversion will be indicated for atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia and, in relatively stable patients, ventricular tachycardia. Pacing will be fixed, or on demand and for patients with symptomatic bradycardia. There is an ‘overdrive’ option within the fixed mode.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0504069
Registration Date
January 24, 2020
Change Notification Approval Date
June 14, 2021
Retention Due Date
January 23, 2026
Product Owner
Short Name
SCHILLER AG
Address
Altgasse 68, CH-6341 Baar Switzerland, SWITZERLAND
Registrant
Address
622 LORONG 1 TOA PAYOH, SINGAPORE 319763
Importer
Address
622 LORONG 1 TOA PAYOH, #L3-NA, SINGAPORE 319763
Model Information
Model Name(s)
Tempus LS Securing Pads ARGUS LifePoint Electrodes for Defibrillation, Adult (> 8 years age / > 25kg) Electrodes for Defibrillation, Paediatric (1-8 years age / < 25kg)
Model Identifier(s)
00-3010 2.100519 2.10086 2.155061 2.155067