EGZOTECH SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ
PL-MF-000003826 · Poland · Gliwice
EGZOTECH SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 6 |
|---|
Most frequent device types declared: Luna EMG.
Among these devices, 6 are declared active, 5 with a measuring function.
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 | 6 |
| 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/0015/4038/2023 | issued | 2026-11-27 |