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Schiller Holter Recorder System - Microvit series - HSA Registration DE0013066

Access comprehensive regulatory information for Schiller Holter Recorder System - Microvit 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 DE0013066 and owned by SCHILLER AG. The device was registered on June 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
DE0013066
Schiller Holter Recorder System - Microvit series
HSA Registration Number: DE0013066
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Product Description

The MT-101/MT-200 Holter and evaluation software is designed to record long term electrocardiograms 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.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
HSA Product Code
HSAMDB00104
HS Code
90181100
Registration Information
Registration Number
DE0013066
Registration Date
June 03, 2013
Retention Due Date
June 02, 2025
Product Owner
Short Name
SCHILLER AG
Address
Altgasse 68, Postfach, CH-6341 Baar, SWITZERLAND
Registrant
Address
211 HENDERSON ROAD, 211 HENDERSON, #13-01, SINGAPORE 159552
Importer
Address
211 HENDERSON ROAD, 211 HENDERSON, #13-01, SINGAPORE 159552 211 HENDERSON ROAD, HENDERSON INDUSTRIAL PARK, #13-01, SINGAPORE 159552
Model Information
Model Name(s)
Microvit MT-200 Kit Analysis Software Microvit MT-101, 2-Channel, IEC Version Microvit MT-101, 2-Channel, US Version Microvit MT-101, 3-Channel, IEC Version Microvit MT-101, 3-Channel, US Version Adhesive Pads for Silicon Pouch (3 pcs) Adhesive Pads for Silicon Pouch (20 pcs) Hook-up Kit Patient Cable, 6-Lead, AHA-Colour Code Patient Cable, 4-Lead, AHA-Colour Code Patient Cable, 6-Lead, IEC-Colour Code Patient Cable, 4-Lead, IEC-Colour Code Patient Cable, 7-Lead, IEC-Colour Code Patient Cable, 7-Lead, AHA-Colour Code Patient Cable, 5-Lead, IEC-Colour Code Patient Cable, 5-Lead, AHA-Colour Code
Model Identifier(s)
0.300000 1.300000 1.300001 1.300010 1.300011 2.100519 2.100520 2.100534 2.400100 2.400101 2.400102 2.400103 2.400136 2.400143 2.400144 2.400145