EU → US Device Access

SINMED SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ

PL-MF-000002789 · Poland · Przyszowice

SINMED SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ is registered in the European database on medical devices as a manufacturer, with 114 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa114

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 registerNot found in the FDA register
Devices in EUDAMED114
Country of registrationPoland
⚠️ 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

CertificateStatusExpiry
TNP/MDR/0056/5944/2026issued2031-05-06

Other manufacturers in Poland

All Poland manufacturers →