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Singapore HSA registration DE0500514

Schiller Cardiovit CS-200 Touch ECG system

Singapore flagSingapore·CLASS B·SCHILLER AG·Registered March 15, 2017
Device classification
Device Class
CLASS B
Medical Speciality Area
Cardiovascular
Registration information
Registration Number
DE0500514
Registration Date
March 15, 2017
Change Notification Approval Date
February 10, 2020
Retention Due Date
March 14, 2026
Product description
The CARDIOVIT CS-200 Touch is a 16-channel ECG device used for the recording, analysis and evaluation of ECG recordings. Recordings made with the CARDIOVIT CS-200 Touch can be used as a diagnostic aid for heart function and heart conditions. It is designed for indoor use and can be used for all patients of both sexes, all races, and all ages.The intended diagnostic applications are the diagnosis of cardiac abnormalities in the general population, detection of acute myocardial ischemia, and detection of infarction in chest pain patients.
Product Owner
Name
SCHILLER AG
Short Name
SCHILLER AG
Address
Altgasse 68, Postfach, 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 Touch SCHILLER Tabs disposable electrodes 500 pcs 10-wire patient cable IEC, 3,5m with clip 10-wire patient cable AHA 3,5m with clip 14-wire patient cable AHA, for 16-lead acquisition, 14-wire patient cable IEC, for 16-lead acquisition 14-wire patient cable AHA, for 16-lead acquisition, 14-wire patient cable IEC, for 16-lead acquisition, Detachable single wires banana plug, 4 pcs, Detachable single wires clip type, 4 pcs, A1 to A4 Detachable single wires AHA banana plug, 6 pcs, Detachable single wires AHA banana plug, 4 pcs, Detachable single wires AHA banana plug, 4 pcs, Detachable single wires AHA clip type, 6 pcs, Detachable single wires AHA clip type, 4 pcs, Detachable single wires AHA clip type, 4 pcs,
Model Identifier(s)
0A.102000 2.155031 2.400095 2.400104 2.400139 2.400140 2.400141 2.400142 2.410082 2.410086 2.410088 2.410089 2.410091 2.410092 2.410093 2.410095
About this record

Access comprehensive regulatory information for Schiller Cardiovit CS-200 Touch ECG system in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0500514 and owned by SCHILLER AG. The device was registered on March 15, 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