EU → North America Device Access

DeMeTec GmbH

DE-MF-000005062 · Germany · Langgöns

DeMeTec GmbH is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa5

Most frequent device types declared: Databox-System, VAS5.

Among these devices, 5 are declared active, 2 with a measuring function.

Devices declared under this manufacturer

Catalogue references include FG-300|FG-299|-FG-303|FG-353, FG-313 + FG-296|FG-297, FG-398, FG-419, FK-089.

European nomenclature codes declared: N010199, Z12100480, Z12100401.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED5
Country of registrationGermany

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

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: Neither register. DeMeTec GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

All Germany manufacturers →