EU → North America Device Access

STE PHARMACEUTICALS, S.L.U

ES-MF-000000144 · Spain · Cerdanyola del Vallès

STE PHARMACEUTICALS, S.L.U is registered in the European database on medical devices as a manufacturer, with 584 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa584

Devices declared under this manufacturer

Showing 12 of 584 declared devices.

Catalogue references include PL0032_120_Soft, PL0033_100_Soft, PL0033_120_Soft, PL0090, PL0112_100_Medium, PL0146_140.

European nomenclature codes declared: Q030103, Q030199, Q03040299, R05010399.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED584
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 GTIN584
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. STE PHARMACEUTICALS, S.L.U was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
002/MDRsupplemented2030-12-04

Other manufacturers in Spain

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