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Schiller Digital Holter Recorder System - Medilog series - HSA Registration DE0012438

Access comprehensive regulatory information for Schiller Digital Holter Recorder System - Medilog series in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0012438 and owned by Schiller AG. The device was registered on February 25, 2013.

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 B
DE0012438
Schiller Digital Holter Recorder System - Medilog series
HSA Registration Number: DE0012438
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Product Description

The ECG Holter is used to record patient's multi-channel ECG and to measure the time intervals between consecutive R peaks in the ECG, for the diagnosis of symptomatic and asymptomatic arrhythmias, i.e. bradycardia or tachycardia, and for patients after resuscitation or suffering from diseases such as cardiomyopathy, high blood pressure or long QT syndrome. Holter recordings are used for the diagnostics of - symptomatic and asymptomatic arrhythmias. - arrhythmias in patients with coronary artery diseases - patients with diseases like cardiomyopathy, high blood pressure, long QT, etc. Holter recordings are used for the diagnostics of - symptomatic and asymptomatic arrhythmias. - arrhythmias in patients with coronary artery diseases - patients with diseases like cardiomyopathy, high blood pressure, long QT, etc.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
HSA Product Code
HSAMDB00112
HS Code
90181100
Registration Information
Registration Number
DE0012438
Registration Date
February 25, 2013
Retention Due Date
February 24, 2026
Product Owner
Short Name
Schiller AG
Address
Altgasse 68, CH-6341 Baar, SWITZERLAND
Registrant
Address
211 HENDERSON ROAD, 211 HENDERSON, #13-01, SINGAPORE 159552
Importer
Address
211 HENDERSON ROAD, HENDERSON INDUSTRIAL PARK, #13-01, SINGAPORE 159552 211 HENDERSON ROAD, 211 HENDERSON, #13-01, SINGAPORE 159552
Model Information
Model Name(s)
Medilog AR4 Plus , 5 lead Medilog AR4 Plus, 7 lead Medilog FD5 Plus, 5 lead Medilog FD5 Plus, 7 lead Medilog AR 12 Plus, 5-Lead Medilog AR 12 Plus, 7-Lead Medilog AR 12 Plus, 3-Lead/1-Channel Patient Cable, 3-Lead, HRV Patient Cable, 5-Lead Patient Cable, 7-Lead Medilog Darwin Professional Medilog Darwin Professional, Add. License Medilog Darwin Scanlab Medilog Darwin ScanLab, Add. License Medilog Darwin Atrial Medilog Darwin HRV Medilog Darwin Demo Software Dongle Medilog Darwin Liberty Medilog Darwin HL7/SAP/BAPI Interface Medilog Darwin BDT/GDT Interface
Model Identifier(s)
1.301000 1.301010 1.302000 1.302010 1.350000 1.350001 1.350002 2.400159 2.400160 2.400161 5.281000 5.281001 5.281002 5.281003 5.281004 5.281005 5.281006 5.281007 5.281008 5.281009