EU → North America Device Access

Rayonex Biomedical GmbH

DE-MF-000007449 · Germany · Lennestadt

Rayonex Biomedical GmbH is registered in the European database on medical devices as a manufacturer, with 20 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa20

Among these devices, 2 are declared active.

Devices declared under this manufacturer

Showing 12 of 20 declared devices.

Catalogue references include 30320, 30328, 30331, 30335, 30336, 314.

European nomenclature codes declared: V9099.

United States market access

FDA establishment registerRegistered with FDA
Matched entryRAYONEX BIOMEDICAL GMBH (DE) · FDA 3011255064
Devices in EUDAMED20
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN20
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: United States only. Rayonex Biomedical GmbH is registered in the United States but was not found in the Canadian register.

Other manufacturers in Germany

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