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Schiller Electrocardiography (ECG) Cardiovit - HSA Registration DE0013756

Access comprehensive regulatory information for Schiller Electrocardiography (ECG) Cardiovit in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0013756 and owned by SCHILLER AG. The device was registered on September 03, 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
DE0013756
Schiller Electrocardiography (ECG) Cardiovit
HSA Registration Number: DE0013756
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Product Description

It is a 12-channel ECG device used for the recording, analysis and evaluation of ECG recordings.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0013756
Registration Date
September 03, 2013
Change Notification Approval Date
June 24, 2021
Retention Due Date
September 02, 2025
Product Owner
Short Name
SCHILLER AG
Address
Altgasse 68, Postfach, 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)
CARDIOVIT AT-102 CARDIOVIT AT-101 CARDIOVIT AT-102 G2 Set of adult ECG electrodes incl. 6 suction electrode set Set of children ECG electrodes incl. 6 suction Suction electrode 4mm Adult clamp extremity electrode, set of 4 pcs Blue Sensor Disposable Stress Test Electrode, SCHILLER Tabs disposable electrodes, 500 pcs Replacement bulb for suction electrode 2.155000 recording paper Electrode gel 50 ml dust cover 10 lead patient cable with banana plugs IEC Patient cable 10-pole AHA 2m, banana plug type 10 lead patient cable IEC, 2m clip 10-lead patient cable IEC, 3.5m clip-type 10-lead patient cable, clip type, 3.5m, AHA C Software AT-102 Basic Ergometry Software AT-102 C Software incl. Thrombolysis recommendation for AT-102 Thrombolysis Recommendation Software AT-102, upgrade from C-Version Worklist Software AT-102 Thrombolysis Recommendation Software AT-101 C Software AT-101 Memory Software for AT-101 C Software incl. Thrombolysis recommendation for AT-101 ETM Software AT-102 G2 (ECG Treatment Module) SCHILLER Culprit Coronary Artery Algorithm Software (CCAA) AT-102 G2 Worklist Software AT-102 G2 Basic Ergometry Software AT-102 G2
Model Identifier(s)
0.070000 0.080000 0A.108000 2.000041 2.000041. 2.000052 2.155000 2.155020 2.155025 2.155031 2.155060 2.157026 2.158000 2.160014 2.400070 2.400071 2.400079 2.400095 2.400104 5.070001 5.070002 5.070003 5.070004 5.070006  5.080001 5.080002 5.080003 5.080004 5.108002 5.108004 5.108005 5.108006