Pure Global
Singapore HSA registration DE0018984

Schiller Cardiovit CS-200 Office

Singapore flagSingapore·CLASS B·Schiller AG·Registered February 16, 2017
Device classification
Device Class
CLASS B
Medical Speciality Area
Cardiovascular
Registration information
Registration Number
DE0018984
Registration Date
February 16, 2017
Change Notification Approval Date
September 28, 2023
Retention Due Date
February 15, 2026
Product description
The CARDIOVIT CS-200 Office is a PC based 12-channel ECG device used for the recording, analysis and evaluation of ECG recordings. It is designed for indoor use and can be used for all patients of both sexes, all races, and all ages and is intended for use in hospitals, cardiologic units, out-patient clinical units, and general physicians offices. The diagnostic applications for which the CARDIOVIT CS-200 Office is intended is in the field of cardiac abnormalities in the general population, detecting acute myocardial ischemia, and infarction in chest pain patients.
Product Owner
Name
Schiller AG
Short Name
Schiller AG
Address
Altgasse 68, CH-6341 Baar, SWITZERLAND
Registrant
Name
Gold Lite Pte Ltd
Address
211 HENDERSON ROAD, 211 HENDERSON, #13-01, SINGAPORE 159552
Importer
Name
Gold Lite Pte Ltd Gold Lite Pte Ltd
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)
CARDIOVIT CS-200 Office CARDIOVIT CS-200 Office Cardiovit MS-12 blue, IEC Version Cardiovit MS-12 blue, AHA Version Amubu BlueSensor R ECG electrodes battery charger 10-wire ECG patient cable snap type IEC version 10-wire ECG patient cable snap type AHA version ETM Software CS-200 Office (ECG Treatment Module) Athletes Heart Software - Seattle Criteria CS-200 Office Vector ECG Software CS-200 Office ETM Re-Interpretation Software CS-200 Office Arrhythmia detection / documentation Software CS-200 Office SCHILLER Exercise 12/16-lead ECG EXEC Expert RISK (risk factors) Software CS-200 Office
Model Identifier(s)
0A.103000 0A.103100 1A.303000 1A.303010 2.155025 2.200179 2.400222 2.400223 5.103002 5.103003 5.103005 5.103006 5.103008 5.103009 5.103010
About this record

Access comprehensive regulatory information for Schiller Cardiovit CS-200 Office in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0018984 and owned by Schiller AG. The device was registered on February 16, 2017.

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 B