EU → US Device Access

diawin Deutschland GmbH

DE-MF-000040108 · Germany · Offenbach am Main

diawin Deutschland GmbH is registered in the European database on medical devices as a manufacturer, with 313 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa313

Most frequent device types declared: Smooth Jazz, Inspo BW 46 EXTRA WIDE, Morning Blue 39 EXTRA WIDE, cloudy orchid 42 medium, Piano Black 39 WIDE .

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 EUDAMED313
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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