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Schiller Cardiovit® CS-200 Excellence Electrocardiograph (ECG) Unit - HSA Registration DE0013082

Access comprehensive regulatory information for Schiller Cardiovit® CS-200 Excellence Electrocardiograph (ECG) Unit in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0013082 and owned by Schiller AG. The device was registered on June 04, 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
DE0013082
Schiller Cardiovit® CS-200 Excellence Electrocardiograph (ECG) Unit
HSA Registration Number: DE0013082
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Product Description

CARDIOVIT CS-200 Excellence is a multichannel electrocardiograpgh device intended to acquire ECG signals from body surface electrodes, record, analyse, display and print ECGs for cardiological diagnosis in adult and paediatric patients. The ErgoSpiro module in CARDIOVIT CS-200 Excellence is intended for medical applications requiring a non-invasive assessment of the cardiopulmonary response to exercise or measurement of energy expenditure using indirect calorimetry. The ErgoSpiro option is intended for use with a CS-200 Excellence as part of a cardiopulmonary exercise testing system.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0013082
Registration Date
June 04, 2013
Change Notification Approval Date
June 18, 2021
Retention Due Date
June 03, 2025
Product Owner
Short Name
Schiller AG
Address
Altgasse 68, CH-6341 Baar, SWITZERLAND
Registrant
Address
196 PANDAN LOOP, PANTECH BUSINESS HUB, #04-29, SINGAPORE 128384
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)
Cadiovit CS-200 Excellence CARDIOVIT CS-200 Excellence ErgoSpiro Set of adult ECG electrodes incl. 6 suction set of reusable electrodes incl. gel Set of children ECG electrodes incl. 6 suction Set of standard accessories ergo belt - for Stress version only. Ergo-belt WSP 80 Suction electrode 4mm Adult clamp extremity electrode, set of 4 pcs Abrasive pads CARDIO-PREPS, pouch of 50 pcs SCHILLER Tabs disposable electrodes 500 pcs SCHILLER Biotabs Ag/AgC, disposable electrodes for resting ECG, box of 500 pcs SNAP-CLIP Adapter for banana-plug cables pouch of 10 pcs Electrode gel 50 ml ECG electrode contact spray, bottle 250 ml 10-lead patient cable IEC, 2m with banana plug 10-lead patient cable AHA 2m with banana plug 10-lead patient cable IEC 3,5m clip 10-lead patient cable, clip type, 3.5m, AHA 14-lead patient cable AHA, clip type, 3.5m with detachable single leads 14-lead patient cable IEC, clip type, 3.5m with detachable single leads 14-lead patient cable AHA, banana plug, 3.5m with detachable single leads 14-lead patient cable IEC, banana plug, 3.5m with detachable single leads Adapter for snap-on fastener, set of 10 pcs Detachable single leads IEC banana plug, 6 pcs, Detachable single leads IEC banana plug, 4 pcs, Detachable single leads banana plug, 4 pcs, Detachable single leads IEC banana plug, 4 pcs, Detachable single leads IEC clip type, 6 pcs, Detachable single leads IEC clip type, 4 pcs, Detachable single leads clip type, 4 pcs, A1 to A4 Detachable single leads IEC clip type, 4 pcs, Detachable single leads AHA banana plug, 6 pcs, Detachable single leads AHA banana plug, 4 pcs, Detachable single leads AHA banana plug, 4 pcs, Detachable single leads AHA clip type, 6 pcs, Detachable single leads AHA clip type, 4 pcs, Detachable single leads AHA clip type, 4 pcs, sales folder HyperQ software HyperQ Software for CS-200 Excellence ETM Software CS-200 Excellence (ECG Treatment Module) Vector ECG Software CS-200 Excellence SCHILLER Exercise 12/16-lead ECG EXEC Expert EXEC plus Software CS-200 Excellence Pacemaker Measurement Software PM SAECG Signal-Averaged ECG Software AF Toolbox Software CS-200 Excellence
Model Identifier(s)
0.035000 0.035100 2.000041 2.000041 2.000052 2.000155 2.100060 2.100060 2.155000 2.155020 2.155030 2.155031 2.155031 2.155032 2.158000 2.158006 2.400070 2.400071 2.400095 2.400104 2.400139 2.400140 2.400141 2.400142 2.410041 2.410080 2.410081 2.410082 2.410083 2.410084 2.410085 2.410086 2.410087 2.410088 2.410089 2.410091 2.410092 2.410093 2.410095 2.520089 4.150271 5.035002 5.035003 5.035005 5.035006 5.035007 5.035008 5.035012