Singapore HSA registration DE0510023
livetec Ingenieurbüro GmbH Cardioline ECG
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 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.
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
About this record
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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