EU → US Device Access

SternMed GmbH

DE-MF-000015421 · Germany · Ravensburg

SternMed GmbH is registered in the European database on medical devices as a manufacturer, with 17 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa17

Most frequent device types declared: Lumax 25 / Lumax 15 / Lumax 5 / Lumax 3/ Lumax 3M / Lumax 1M, Onex 101 / Onex 102 / Onex 201 / Onex 202 / Onex 203, Marcom 0.35T / Marcom 0.5T / Marcom 1.5T, Sonos 10 / Sonos 12, Pump Docking Station PDS-4.

Among these devices, 11 are declared active, 5 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 EUDAMED17
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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