EU → US Device Access

S.E. Carburos Metálicos, S.A.

ES-MF-000003117 · Spain · Cornella de Llobregat

S.E. Carburos Metálicos, S.A. is registered in the European database on medical devices as a manufacturer, with 81 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb42
Class IIa39

Most frequent device types declared: CMedic wall‑mounted terminal unit, CMedic terminal unit for articulated equipment, CMedic Aerial Terminal Units, CMedic terminal unit for non‑articulated equipment, AREA SHUT-OFF PANEL - 3 GASES.

Among these devices, 70 are declared active.

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 EUDAMED81
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.

Notified body certificates

CertificateStatusExpiry
ES24/00000069issued2029-01-09
ES/00000039issued2029-01-09

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