EU → US Device Access

Deltalab, S.L.

ES-MF-000000153 · Spain · Rubi

Deltalab, S.L. is registered in the European database on medical devices as a manufacturer, with 275 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

other192
Class IIa83

Most frequent device types declared: RECIPIENTES PARA LA RECOGIDA DE ORINA - URINE COLLECTION CONTAINERS, RECIPIENTES PARA LA RECOGIDA DE SANGRE - BLOOD COLLECTION DEVICES, ESPATULA DE AYRE ESTÉRIL - STERILE AYRE SPATULA, ESPATULA DE AYRE - AYRE SPATULA , DEPRESOR LINGUAL ESTÉRIL - STERILE TONGUE DEPRESSOR.

Among these devices, 67 are declared sterile.

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 EUDAMED275
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
2024 PR 0038issued2029-10-21

Other manufacturers in Spain

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