EU → US Device Access

Sutter Medizintechnik GmbH

DE-MF-000005544 · Germany · Emmendingen

Sutter Medizintechnik GmbH is registered in the European database on medical devices as a manufacturer, with 723 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIb603
Class IIa120

Among these devices, 44 are declared sterile, 679 reusable, 723 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 entrySUTTER MEDIZINTECHNIK GMBH (DE) · FDA 8044091
Devices in EUDAMED723
Country of registrationGermany

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