POWERFUL MEDICAL s.r.o.
SK-MF-000015799 · Slovakia · Bratislava
POWERFUL MEDICAL s.r.o. is registered in the European database on medical devices as a manufacturer, with 13 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 13 |
|---|
Most frequent device types declared: PMcardio®, PMcardio® Core AI ECG Model, PMcardio® OMI AI ECG Model.
Among these devices, 13 are declared active.
Devices declared under this manufacturer
- PMcardio
- PMcardio® Core AI ECG Model
- PMcardio® OMI AI ECG Model
Showing 12 of 13 declared devices.
Catalogue references include Core AI ECG Model, OMI AI ECG Model 1.0, PMcardio 2.6 (Android), PMcardio 2.6 (iOS), PMcardio 2.7 (Android), PMcardio 2.7 (iOS).
European nomenclature codes declared: Z12050392, C020599.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 13 |
| Country of registration | Slovakia |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 13 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. POWERFUL MEDICAL s.r.o. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G10 112750 0001 | issued | 2027-05-04 |