EU → US Device Access

ARTIQO GmbH

DE-MF-000007336 · Germany · Lüdinghausen

ARTIQO GmbH is registered in the European database on medical devices as a manufacturer, with 503 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class I320
Class IIa183

Most frequent device types declared: 7411-0211, 4801-RW09, 4811-LW08, 311406, 4811-RS02.

Among these devices, 320 are declared sterile, 320 implantable, 183 reusable, 1 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 registerNot found in the FDA register
Devices in EUDAMED503
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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