EU → US Device Access

Falcon Medical Medizinische Spezialprodukte GmbH

AT-MF-000001607 · Austria · Mödling

Falcon Medical Medizinische Spezialprodukte GmbH is registered in the European database on medical devices as a manufacturer, with 314 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa259
Class I55

Most frequent device types declared: Instrumente IIa Raspel Metall, Instrumente Ir Funktionsüberprüfung Implantat Metall, Implantate Klasse III Pfanne besch., Instrumente IIa Allgemein Metall, Instrumente Ir Verspreizung Implantat Metall.

Among these devices, 55 are declared sterile, 55 implantable, 243 reusable, 44 with a measuring function.

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 EUDAMED314
Country of registrationAustria
⚠️ 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.

Notified body certificates

CertificateStatusExpiry
D4007300015issued2031-08-03
D4007300014issued2031-07-26
D4007300013issued2031-06-09

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