EU → US Device Access

eucatech AG

DE-MF-000005541 · Germany · Weil am Rhein

eucatech AG is registered in the European database on medical devices as a manufacturer, with 282 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class I201
Class IIb80
Class IIa1

Among these devices, 282 are declared sterile, 172 implantable.

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 EUDAMED282
Country of registrationGermany
⚠️ 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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