EU → US Device Access

H. + H. Maslanka Chirurgische Instrumente GmbH

DE-MF-000005600 · Germany · Tuttlingen

H. + H. Maslanka Chirurgische Instrumente GmbH is registered in the European database on medical devices as a manufacturer, with 147 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa147

Among these devices, 3 are declared sterile, 137 reusable, 9 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 entryH.+H. Maslanka Chirurgische Instrumente GmbH (DE) · FDA 3008808042
Devices in EUDAMED147
Country of registrationGermany

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