Elektronika i Elektromedycyna M.Lewandowski Sp.J.
PL-MF-000032400 · Poland · Otwock
Elektronika i Elektromedycyna M.Lewandowski Sp.J. is registered in the European database on medical devices as a manufacturer, with 76 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 76 |
|---|
Most frequent device types declared: Electrotherapy equipment - Electrode, Electrotherapy equipment - pad, Electrotherapy equipment – cable, Electrotherapy equipment – band, Magnetotherapy equipment .
Among these devices, 14 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 | 76 |
| Country of registration | Poland |
⚠️ 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 |
|---|---|---|
TNP/MDR/0030/2034/2025 | issued | 2028-01-16 |