EU → North America Device Access

GASPUNT, S.A.

ES-MF-000004842 · Spain · CERVERA

GASPUNT, S.A. is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa7

Among these devices, 4 are declared sterile.

Devices declared under this manufacturer

Catalogue references include SO132001, SO132002, SO132004, SOTNT001, VECR0401, VECR0402.

European nomenclature codes declared: M0201050101, M0303010101, M030101, M0202010101.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED7
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 GTIN7
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. GASPUNT, S.A. was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
2025 PR 0063issued2030-10-23

Other manufacturers in Spain

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