EU → North America Device Access

Novoxel GmbH

DE-MF-000012740 · Germany · Berlin

Novoxel GmbH is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa6

Most frequent device types declared: MPH00001, MSH00001, MSTX0002, THLM0002, TPH00001.

Among these devices, 6 are declared active.

Devices declared under this manufacturer

Catalogue references include MPH00001, MSH00001, MSTX0002, THLM0002, TPH00001, TXLD0012.

European nomenclature codes declared: Z12040203,Z12040218.

United States market access

FDA establishment registerRegistered with FDA
Matched entryNOVOXEL LTD. (IL) · FDA 3014193078
Devices in EUDAMED6
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN6
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. Novoxel GmbH is registered in the United States but was not found in the Canadian register.

Other manufacturers in Germany

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