EU → North America Device Access

ENVASES FARMACÉUTICOS, S.A.

ES-MF-000000902 · Spain · Paracuellos de Jarama (Madrid)

ENVASES FARMACÉUTICOS, S.A. is registered in the European database on medical devices as a manufacturer, with 51 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa9

Most frequent device types declared: Cuña sanitaria, Orinal masculino, Recipiente muestra de orina 24 horas, Recipiente muestra de orina con sistema de transferencia integrado (24, Recipiente orina con STI (100 ml).

Among these devices, 4 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 51 declared devices.

Catalogue references include 186612, 70H, 72D, 76F, 76O, 76VAM.

European nomenclature codes declared: W050301029099, V0812.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED51
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 GTIN51
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. ENVASES FARMACÉUTICOS, S.A. was not found in either the U.S. or the Canadian register.

Other manufacturers in Spain

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