EU → US Device Access

Löwenstein Medical Technology GmbH + Co. KG

DE-MF-000006010 · Germany · Hamburg

Löwenstein Medical Technology GmbH + Co. KG is registered in the European database on medical devices as a manufacturer, with 36 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa36

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 registerNot found in the FDA register
Devices in EUDAMED36
Country of registrationGermany
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

Notified body certificates

CertificateStatusExpiry
HZ 1010032-1issued2025-03-10
HZ 1010032-1reissued2030-03-10

Other manufacturers in Germany

All Germany manufacturers →