EU → North America Device Access

Axilum Robotics

FR-MF-000001731 · France · SCHILTIGHEIM

Axilum Robotics is registered in the European database on medical devices as a manufacturer, with 17 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa17

Most frequent device types declared: TMS-Cobot-2, TMS-Explorer-1.

Among these devices, 17 are declared active.

Devices declared under this manufacturer

Showing 12 of 17 declared devices.

Catalogue references include 2-02-02, 2-02-08, 2-02-16, 2-02-18, 2-02-19, 2-02-21.

European nomenclature codes declared: Z12101199.

United States market access

FDA establishment registerRegistered with FDA
Matched entryAxilum Robotics (FR) · FDA 3014805507
Devices in EUDAMED17
Country of registrationFrance

Device-level evidence

Devices with a numeric GTIN17
Found in the U.S. device database6
Share35.3 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryAXILUM ROBOTICS

North American profile: Both markets. Axilum Robotics is registered in both the United States and Canada.

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