EU → US Device Access

Primed Halberstadt Medizintechnik GmbH

DE-MF-000004967 · Germany · Halberstadt

Primed Halberstadt Medizintechnik GmbH is registered in the European database on medical devices as a manufacturer, with 1 831 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb1 190
Class IIa641

Most frequent device types declared: Trachealkanüle, (Ersatz-) Innenkanülen Optima, Ultrasoft, ProLine, Silberkanülen, Brachytherapie-Nadeln mit Goldmarker, (Ersatz-) Innenkanülen Primedistom.

Among these devices, 1 455 are declared sterile, 118 implantable.

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 831
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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