KARDI AI Technologies s.r.o.
Czechia CZ-MF-000026438 Last updated 17 Sep 2026
- Devices
- 1
- Registries
- EUDAMED
- FDA recalls
- 0
Catalogue
Kardi Ai Ref Kardi Ai
EUDAMED certificates
Notified body 1023 1 certificate
- 24 0263 QR/NB Reinstated
Quality management system EU MDR
- Issued
- 29 Jul 2024
- Expires
- 28 Jul 2029
- Reason
- Issue resolved
Related companies
Notified bodies
- Notified body 1023
About
Kardi service Ai connects ECG recording equipment in the form of a comfortable chest belt with a unique application that is certified as a medical device. The application will monitor the rhythm of your heart and alert you immediately in case of irregularities. At the same time, it generates a detailed report on your heart rate for your doctor.
What KARDI AI Technologies s.r.o. makes
Kardi AI Technologies produces a Class IIa medical device combining a wearable chest belt for ECG recording with a mobile application. The system continuously monitors heart rhythm and provides real-time alerts for irregularities, while also generating detailed heart rate reports for clinical review.
The device is listed in the EU’s eudamed registry under Class IIa classification. The company is based in the Czech Republic.
Frequently asked questions
What types of medical devices does Kardi AI Technologies manufacture?
Kardi AI Technologies manufactures a Class IIa medical device called Kardi Ai. This system consists of a wearable chest belt for ECG recording paired with a mobile application. The device continuously monitors heart rhythm and provides real-time alerts for irregularities, while also generating detailed heart rate reports for doctors to review.
Where is Kardi AI Technologies based?
Kardi AI Technologies is based in the Czech Republic. The company’s headquarters and operations are located within this country.
Which regulatory registries list Kardi AI Technologies’ devices?
Kardi AI Technologies’ devices are listed in the EU’s eudamed registry. This database is used to track medical devices authorised within the European Economic Area, ensuring transparency and traceability.
How are Kardi AI Technologies’ devices classified?
Kardi AI Technologies’ devices fall under Class IIa classification. This classification is determined by the level of risk associated with the device, with Class IIa indicating moderate risk, typically requiring additional scrutiny and compliance measures to ensure safety and performance.
Information
- Country
- Czechia
- Address
- 459/11, 28. října, OLOMOUC, Czechia
- Website
- www.kardi.ai
- linkedin.com/company/kardi-ai
- facebook.com/KardiAI
- [email protected]
- Phone
- +420779998100
- PRRC contact
- Eva Orendášová
- EUDAMED SRN
- CZ-MF-000026438