EU → North America Device Access

Focal Meditech BV

NL-MF-000000536 · Netherlands · Tilburg

Focal Meditech BV is registered in the European database on medical devices as a manufacturer, with 22 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa22

Most frequent device types declared: Rise Up.

Among these devices, 17 are declared active.

Devices declared under this manufacturer

Showing 12 of 22 declared devices.

Catalogue references include 600097, 600236, 601589, 605540, 605988, 606913.

European nomenclature codes declared: Y240999, Y181899, Y241899, Y122499, Y150999.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED22
Country of registrationNetherlands

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

Device-level evidence

Devices with a numeric GTIN22
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. Focal Meditech BV was not found in either the U.S. or the Canadian register.

Other manufacturers in Netherlands

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