EU → US Device Access

Hans Hepp GmbH & Co. KG

DE-MF-000006024 · Germany · Hamburg

Hans Hepp GmbH & Co. KG is registered in the European database on medical devices as a manufacturer, with 167 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa167

Among these devices, 58 are declared sterile.

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 entryHANS HEPP GMBH & CO. KG (DE) · FDA 3003364331
Devices in EUDAMED167
Country of registrationGermany

Notified body certificates

CertificateStatusExpiry
0462GB449230328amended2027-10-19

Other manufacturers in Germany

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