EU → US Device Access

Starmed

DE-MF-000026331 · Germany · Stetten am Bodensee

Starmed is registered in the European database on medical devices as a manufacturer, with 12 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa12

Most frequent device types declared: ITS Terra 100, ECMO-CARRIER for Lifemotion® ECMO unit, Heavystar.

Among these devices, 10 are declared active.

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 registerRegistered with FDA
Matched entrySTARMED CO.,LTD (KR) · FDA 3013557681
Devices in EUDAMED12
Country of registrationGermany

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