Cardiomatics Sp. z o.o.
Active in EUDAMEDPolandfrom SRN EUDAMED SRN PL-MF-000019811
- Devices
- 1
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
Catalogue
- CE MDR EUDAMED
Company details
- EUDAMED SRN
- PL-MF-000019811
- EU VAT number
- PL6772389521
- EUDAMED status
- Active
- EUDAMED registered name
- Cardiomatics Sp. z o.o.
- EUDAMED abbreviated name
- Cardiomatics
- Registered address
- 7, Wojciecha Weissa, 31-339, Kraków, Poland
- Website
- cardiomatics.com
- [email protected]
- Phone
- +48 790 261 534
- PRRC contact
- Piotr Nowak
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 10 Oct 2028
TÜV Rheinland LGA Products GmbH 0197 1 certificate
- HZ 1370539-1 Issued
Quality management system EU MDR
- Issued
- 11 Oct 2023
- Expires
- 10 Oct 2028
From the company website
Cardiomatics is an artificial intelligence (AI), cloud-based medical grade software (CE/MDR) for analysing Ambulatory (Holter) ECG tests. The system uses clinically validated AI algorithms to provide accurate and high-quality results.
Frequently asked questions
How many devices does Cardiomatics Sp. z o.o. have in the registry?
The registry currently lists 1 device for Cardiomatics Sp. z o.o.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cardiomatics Sp. z o.o.'s devices?
Among its 1 most recently registered device, Cardiomatics Sp. z o.o. has devices listed in EUDAMED (1 device).
What risk classes do Cardiomatics Sp. z o.o.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Cardiomatics Sp. z o.o.'s devices are Class IIa. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Cardiomatics Sp. z o.o.?
EUDAMED lists 1 certificate for Cardiomatics Sp. z o.o. (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 2023-10-11.
What are the newest devices from Cardiomatics Sp. z o.o. in the registry?
The most recently registered devices listed for Cardiomatics Sp. z o.o. include Cardiomatics – Standalone software for ECG signal analysis.