EU → US Device Access

BARNA IMPORT MEDICA, S.A.

ES-MF-000000226 · Spain · Molins de Rei (Barcelona)

BARNA IMPORT MEDICA, S.A. is registered in the European database on medical devices as a manufacturer, with 342 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa342

Most frequent device types declared: Cobertura / vestuario quirúrgico no estéril, Guantes de examen de nitrilo no estériles, Absorbentes pants para incontinencia, Absorbentes elásticos para incontinencia, Tiras adhesivas de plástico.

Among these devices, 65 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 EUDAMED342
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
2023 PR 0004issued2028-09-26

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