EU → US Device Access

Josef Nehonský

CZ-MF-000006581 · Czechia · Plzeň

Josef Nehonský is registered in the European database on medical devices as a manufacturer, with 85 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa85

Most frequent device types declared: Ortéza kolene se stabilizací čéšky GE003SP, Ortéza zápěstní rigidní CA001R , Límec krční měkký C001M, Límec krční měkký s výztuhou C002MP, Pás bederní s výztuhami LU001P.

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 EUDAMED85
Country of registrationCzechia
⚠️ 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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