EU → North America 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: Absorbentes elásticos para incontinencia, Absorbentes pants para incontinencia, Apósito adhesivo de poliuretano transparente con compresa central de v, Batas de aislamiento / protección, Cobertura / vestuario quirúrgico no estéril.

Among these devices, 65 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 342 declared devices.

Catalogue references include 101026, 121300, 130354, 148468, 169107, 186439.

European nomenclature codes declared: T0299, T01020204, M04010101, T04010103, T04010199, M04040601.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED342
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 GTIN342
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. BARNA IMPORT MEDICA, S.A. was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
2023 PR 0004issued2028-09-26

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