EU → North America Device Access

Entusia BV

BE-MF-000007880 · Belgium · Vosselaar

Entusia BV is registered in the European database on medical devices as a manufacturer, with 27 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa27

Most frequent device types declared: Entusia.

Devices declared under this manufacturer

Showing 12 of 27 declared devices.

Catalogue references include 05430000433006, 05430000433198, 05430000433204, 05430000433235, 05430000433433, 05430000433440.

European nomenclature codes declared: T04010199.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED27
Country of registrationBelgium

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

Device-level evidence

Devices with a numeric GTIN27
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. Entusia BV was not found in either the U.S. or the Canadian register.

Other manufacturers in Belgium

All Belgium manufacturers →