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livetec Ingenieurbüro GmbH Cardioline ECG - HSA Registration DE0510023

Access comprehensive regulatory information for livetec Ingenieurbüro GmbH Cardioline ECG in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510023 and owned by livetec Ingenieurbüro GmbH. The device was registered on November 08, 2024.

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
DE0510023
livetec Ingenieurbüro GmbH Cardioline ECG
HSA Registration Number: DE0510023
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Product Description

The Intended of use for the device is for the continuous measurement and digital storage of ECG signals during the patient’s daily activities as part of a long-term/Holter ECG. The recorded data are used to diagnose cardiac arrhythmias. The recorded data is downloaded from CARDIOLINE Walk Free to a PC in a medical facility and evaluated with a suitable Holter-EKG analysis software. A doctor evaluates the normal and abnormal ECG data for further therapeutic measures.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0510023
Registration Date
November 08, 2024
Retention Due Date
November 07, 2025
Product Owner
Short Name
livetec Ingenieurbüro GmbH
Address
Marie-Curie-Str. 8, 79539 Lörrach, GERMANY
Registrant
Address
192 PANDAN LOOP, PANTECH BUSINESS HUB, #07-22, SINGAPORE 128381
Importer
Address
192 PANDAN LOOP, PANTECH BUSINESS HUB, #07-22, SINGAPORE 128381
Model Information
Model Name(s)
Wireless ECG Holter Recorder - Cardioline ECG
Model Identifier(s)
105660