EU → North America 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

Class IIa83

Most frequent device types declared: APLICADOR NO ESTÉRIL CON PUNTA ABSORBENTE - ABSORBENT TIPPED APLICATOR, COLORANTES DE HEMATOLOGÍA Y TINCIÓN VITAL RETICULOCITOS - HAEMATOLOGIC, DEPRESOR LINGUAL ESTÉRIL - STERILE TONGUE DEPRESSOR, ESCOBILLÓN ESTÉRIL CON Y SIN MEDIO DE TRANSPORTE STERILE SAMPLE COLLE, ESCOBILLÓN FLOCADO DE NYLON ESTÉRIL CON SOPORTE DE ABS ROMPIBLE CON Y .

Among these devices, 67 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 275 declared devices.

Catalogue references include 182295F, 202842, 300290, 309202V, 400500.B, 621101.

European nomenclature codes declared: W05019099, W05010203, A1102, A1101, W050101010201, U089002.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED275
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 GTIN275
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. Deltalab, S.L. was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
2024 PR 0038issued2029-10-21

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