EU → US Device Access

T.P.H. Pol-Intech Sp. z o.o.

PL-MF-000007168 · Poland · Łódź

T.P.H. Pol-Intech Sp. z o.o. is registered in the European database on medical devices as a manufacturer, with 160 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa160

Most frequent device types declared: Instrument do opracowywania wypełnień, Zgłębnik, Dwupętlowa z zamkiem do ściągania mostów, Rękojeść do lusterka, YDM-Pro.

Among these devices, 1 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 registerNot found in the FDA register
Devices in EUDAMED160
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.

Other manufacturers in Poland

All Poland manufacturers →