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Schiller medilogAR - HSA Registration DE0504028

Access comprehensive regulatory information for Schiller medilogAR in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0504028 and owned by Schiller AG. The device was registered on January 14, 2020.

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
DE0504028
Schiller medilogAR
HSA Registration Number: DE0504028
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Product Description

The medilogAR is used to record a 3-channel ECG. The recorder is designed for a measuring duration of more than 24 hours and is therefore worn by the patient throughout the day. The preparation for the recording (attaching electrodes, etc.) is performed by the technician or doctor. Indicated for use on adults and paediatric (>=10kg) patients (healthy or not). A Holter recording/analysis is indicated if the patient is suspected to suffer from: – cardiac arrhythmias (VT, SVT, Blocks, Tachycardia, Bradycardia…) – ST-depression/elevation – long QT – pacemaker failure – respiratory events

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0504028
Registration Date
January 14, 2020
Change Notification Approval Date
June 18, 2021
Retention Due Date
January 13, 2026
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
Model Information
Model Name(s)
medilogAR Holter pouch single use Shoulder- and waiststrap medilog recorder ECG 5-wire patient cable medilog 0.8m ECG 7-wire patient cable medilog 0.8m Protective case medilogAR medilogAR medilog DARWIN2
Model Identifier(s)
1A.306000 2.156086 2.156096 2.400176 2.400177 2.610063 3.92074 medilog DARWIN2