EU → US Device Access

MEDIGMA BIOMEDICAL GMBH

DE-MF-000009412 · Germany · Wehingen

MEDIGMA BIOMEDICAL GMBH is registered in the European database on medical devices as a manufacturer, with 1 441 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa809
Class IIb632

Most frequent device types declared: Dental Abutment, Dental Accessory, Drill Stopper, Konisch Implant, Tools.

Among these devices, 177 are declared sterile, 639 implantable, 362 reusable.

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 EUDAMED1 441
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.

Other manufacturers in Germany

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