EU → US Device Access

BYTEC Legal Manufacturer GmbH

DE-MF-000044028 · Germany · Eschweiler

BYTEC Legal Manufacturer GmbH is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa5

Most frequent device types declared: T02-FXONE-01-01, 03PH90, 02PH58.

Among these devices, 1 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 registerRegistered with FDA
Matched entryBYTEC LEGAL MANUFACTURER GMBH (DE) · FDA 3045857305
Devices in EUDAMED5
Country of registrationGermany

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