EU → US Device Access

Unbescheiden GmbH

DE-MF-000007639 · Germany · Baden-Baden

Unbescheiden GmbH is registered in the European database on medical devices as a manufacturer, with 61 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa61

Most frequent device types declared: Automatische Massagewanne, 1.5-3/ 1.4-30/ 1.4-10/ 1.4-4/ 1.4-2/ 1.4-2a, 0.9-9/ 0.9-8/ 0.9-6/ 2.15-1/ 2.17-1/ 2.19-1, 0.20-0/ 0.20-8/ 0.30-0/ 0.30-8, 0.20-3/ 0.30-3/ 0.20-4/ 0.30-4.

Among these devices, 61 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 EUDAMED61
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

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