EU → US Device Access

Medima Spółka z ograniczoną odpowiedzialnością

PL-MF-000023052 · Poland · Warszawa

Medima Spółka z ograniczoną odpowiedzialnością 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 IIa13

Most frequent device types declared: DS102, DS104, DS106, DS108, DS102D, DS202, DS204, DS206, DS208, DS202D, DS102A, DS102AC, ST 01.

Among these devices, 5 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 EUDAMED13
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.

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