EU → North America 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: 02PH58, 03PH90, T02-FXONE-01-01.

Among these devices, 1 are declared active.

Devices declared under this manufacturer

Catalogue references include 02PH58, 03PH90, 03QA17, 03QA18, T02-FXONE-01-01.

European nomenclature codes declared: Q020680, A03010202.

United States market access

FDA establishment registerRegistered with FDA
Matched entryBYTEC LEGAL MANUFACTURER GMBH (DE) · FDA 3045857305
Devices in EUDAMED5
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN5
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: United States only. BYTEC Legal Manufacturer GmbH is registered in the United States but was not found in the Canadian register.

Other manufacturers in Germany

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