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® OMI AI ECG Model, PMcardio® Core AI ECG Model.
Among these devices, 13 are declared active.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 13 |
| Country of registration | Slovakia |
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G10 112750 0001 | issued | 2027-05-04 |