EU → North America Device Access

Laboratorios URGO S.L.

ES-MF-000000629 · Spain · Hernani

Laboratorios URGO S.L. is registered in the European database on medical devices as a manufacturer, with 46 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa46

Most frequent device types declared: FÓRMULA ESPECIAL MANZANILLA, FÓRMULA EXTRAFUERTE, FÓRMULA MAS, FÓRMULA NF-305, FÓRMULA NF-306.

Devices declared under this manufacturer

Showing 12 of 46 declared devices.

Catalogue references include 601724, 604239, 604843, ES0003670, ES0005041, ES0005259.

European nomenclature codes declared: P01020180.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED46
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 GTIN46
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. Laboratorios URGO S.L. was not found in either the U.S. or the Canadian register.

Other manufacturers in Spain

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