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Is kECG-3 (Kardiobeat.ai) certified as a medical device?

kECG-3 (Kardiobeat.ai) by livetec Ingenieurbüro GmbH is listed in EUDAMED as a CE class IIa medical device. A notified body certificate is linked to the device record in EUDAMED. We found no FDA authorisation.

At a glance

Product	kECG-3 (Kardiobeat.ai)
Maker	livetec Ingenieurbüro GmbH
Care area	Heart & circulation
What it does	Mobile ECG system with software for recording and AI-supported analysis
FDA	No FDA authorisation found
EU (CE)	Class IIa
EU certificate	Linked to the device record in EUDAMED (checked 18 October 2026)
Website	kardiobeat.ai
Status	CE verified
Last checked	6 October 2026

Certification status can change. Always confirm in the official register before relying on it: the FDA databases, EUDAMED or the BfArM DiGA directory.

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