EU → US Device Access

Fabryka Narzędzi Medycznych Chirmed Marcin Dyner Spółka Komandytowa

PL-MF-000052302 · Poland · RUDNIKI

Fabryka Narzędzi Medycznych Chirmed Marcin Dyner Spółka Komandytowa is registered in the European database on medical devices as a manufacturer, with 2 045 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa2 045

Most frequent device types declared: Pinceta mikrochirurgiczna z okrągłą rączką ,,piłka golfowa\, Narzędzia do wypełnień\t\t\t \t\t\t, Drut do klamer ortonyksyjnych, Mikropinceta do wiązania szwów z okrągłą rączką ,,piłka golfowa\, Pinceta mikrochirurgiczna z okrągłą rączką , piłka golfowa\.

Among these devices, 1 893 are declared reusable.

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 EUDAMED2 045
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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