EU → North America 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: Happy Yellow 36 EXTRA WIDE, Inspo BW 41 WIDE, Inspo BW 44 MEDIUM, Morning Blue 39 EXTRA WIDE, Piano Black 39 WIDE.

Devices declared under this manufacturer

Showing 12 of 313 declared devices.

Catalogue references include AF17421, AM18393, DI11351, DI11372, TF26363, TM32412.

European nomenclature codes declared: Y063303.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED313
Country of registrationGermany

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN313
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: Neither register. diawin Deutschland GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

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