EU → North America Device Access

Calvo Izquierdo S.L.

ES-MF-000001063 · Spain · Requena

Calvo Izquierdo S.L. is registered in the European database on medical devices as a manufacturer, with 446 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa446

Devices declared under this manufacturer

Showing 12 of 446 declared devices.

Catalogue references include 10561, 11118, 11202, 11218-51 AZUL/BLUE, 11262-01 AZUL/BLUE, 11916.

European nomenclature codes declared: M0303010201, M0303010101, M030299, M03030103, Z120603, M030403.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED446
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 GTIN446
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. Calvo Izquierdo S.L. was not found in either the U.S. or the Canadian register.

Other manufacturers in Spain

All Spain manufacturers →