EU → North America Device Access

BADER EUROPE GROUP S.L.

ES-MF-000041884 · Spain · Nigrán (Pontevedra)

BADER EUROPE GROUP S.L. is registered in the European database on medical devices as a manufacturer, with 219 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa219

Among these devices, 2 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 219 declared devices.

Catalogue references include 10/012, 17/4011, 17/4013-2, 17/4034-5, 17/4034-7, 17/4045.

European nomenclature codes declared: Q010599.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED219
Country of registrationSpain

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

Device-level evidence

Devices with a numeric GTIN219
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. BADER EUROPE GROUP S.L. was not found in either the U.S. or the Canadian register.

Other manufacturers in Spain

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