EU → North America Device Access

Spinreact S.A.U.

ES-MF-000011023 · Spain · Sant Esteve de Bas

Spinreact S.A.U. is registered in the European database on medical devices as a manufacturer, with 638 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Most frequent device types declared: 0, NO, No.

Devices declared under this manufacturer

Showing 12 of 638 declared devices.

Catalogue references include 1205062, 1700039, 1709104, 41222, MD41250, MX1001065.

European nomenclature codes declared: W0105011002, W0105011799, W01021109, W01010207, W01010230, W01010213.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED638
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 GTIN638
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. Spinreact S.A.U. was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
HX 1552211-1supplemented2030-02-04

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