EU → US Device Access

spektramed GmbH

DE-MF-000005711 · Germany · Wegberg

spektramed GmbH is registered in the European database on medical devices as a manufacturer, with 163 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa163

Most frequent device types declared: ErgoSpine ohne Mobilisierungsfunktion mit Adapter, ErgoSpine Pro ohne Mobilisierungsfunktion mit Adapter, ErgoSpine Pro mit Mobilisierungsfunktion mit Adapter, ErgoSpine mit Mobilisierungsfunktion mit Adapter, ErgoPro lordosierend.

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 EUDAMED163
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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