EU → US Device Access

Zakład elektromechaniczny Erhem Hończak i wspólnicy sp.j

PL-MF-000004773 · Poland · Debica

Zakład elektromechaniczny Erhem Hończak i wspólnicy sp.j is registered in the European database on medical devices as a manufacturer, with 117 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa117

Most frequent device types declared: ERH-42/3 L, ERH-35/Z/K-1 L, ERH-49/1 L M, ERH-51, ERH-35/Z/K-S L.

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 EUDAMED117
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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