Singapore HSA registration DE0504069
Schiller Tempus LS Defibrillator
Singapore·CLASS C·SCHILLER AG·Registered January 24, 2020Device 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 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.
Product Owner
- Name
- SCHILLER AG
- 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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C