Medicalgorithmics S.A.
PL-MF-000011413 · Poland · Warsaw
Medicalgorithmics S.A. is registered in the European database on medical devices as a manufacturer, with 15 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 15 |
|---|
Most frequent device types declared: P4TR-CE-ADS.
Among these devices, 15 are declared active, 6 with a measuring function.
Devices declared under this manufacturer
- DeepRhythm Platform
- DeepRhythmAI
- PC Client
- PocketECG IV
- Virtual Cardiac Stress Test (VCAST)
Showing 12 of 15 declared devices.
Catalogue references include 05903021560186, 05903021560230, 05903021560247, 05903021560346, 05903021560759, 05903021560810.
European nomenclature codes declared: Z129092, Z12050403, Z119092.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | MEDICALGORITHMICS S.A. (PL) · FDA 3007770164 |
| Devices in EUDAMED | 15 |
| Country of registration | Poland |
Device-level evidence
| Devices with a numeric GTIN | 15 |
|---|---|
| Found in the U.S. device database | 3 |
| Share | 20.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | MEDICALGORITHMICS S.A. |
What it holds in Canada
| Licences on record | 5 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 5 |
| First licensed | 2014-04-02 |
Licence types: System (3), Single Device (2).
Licensed under: MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTI, UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM POCKETECG, KARDIOBEAT.AI, DEEPRHYTHMAI, DEEPRHYTHM PLATFORM.
North American profile: Both markets. Medicalgorithmics S.A. is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HZ 1023833-1 | supplemented | 2028-03-28 |