EU → US Device Access

PROMECHI, S.L.

ES-MF-000010973 · Spain · ALACUAS - VALENCIA

PROMECHI, S.L. is registered in the European database on medical devices as a manufacturer, with 124 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb122
Class IIa2

Most frequent device types declared: CANULA DE PLATA FONATORIA Nº 4 - 10 x 68 mm, CÁNULA LARGO ESPECIAL FENESTRADA Nº 1 - 7 x 93 mm, CANULA DE TRAQUEOTOMIA PLATA FENESTRADA Nº 00 - 5 x 42 mm, CANULA DE TRAQUEOTOMIA DE PLATA Nº 8 - 2 PIEZAS - 14 x 80 mm, CANULA DE PLATA LARGO ESPECIAL Nº 3 - 9 x 97 mm.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED124
Country of registrationSpain
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

Other manufacturers in Spain

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