EU → North America 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, Marcom 0.35T / Marcom 0.5T / Marcom 1.5T, Onex 101 / Onex 102 / Onex 201 / Onex 202 / Onex 203, Pump Docking Station PDS-4, Sonos 10 / Sonos 12.

Among these devices, 11 are declared active, 5 with a measuring function.

Devices declared under this manufacturer

Showing 12 of 17 declared devices.

Catalogue references include 1160120, 1160160, 3100105, 3101100, 3101150, 3101200.

European nomenclature codes declared: Z12011202, Z12010701, Z11059099, Z129004, Z11040104, Z12030399.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED17
Country of registrationGermany

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN17
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: Neither register. SternMed GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

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