EU → US Device Access

Dr. Kleine Pharma GmbH

DE-MF-000006589 · Germany · Bielefeld

Dr. Kleine Pharma GmbH is registered in the European database on medical devices as a manufacturer, with 21 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa14
Class IIb7

Most frequent device types declared: 073.1, 443.1, 284.1 .

Among these devices, 1 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 registerNot found in the FDA register
Devices in EUDAMED21
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.

Other manufacturers in Germany

All Germany manufacturers →