EU → North America Device Access

VEC MEDICAL SPAIN, S.L.

ES-MF-000002992 · Spain · MONTCADA I REIXAC .BARCELONA

VEC MEDICAL SPAIN, S.L. is registered in the European database on medical devices as a manufacturer, with 22 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa13
Class IIb8
Class I1

Most frequent device types declared: 27001.

Among these devices, 20 are declared sterile, 8 active.

Devices declared under this manufacturer

Showing 12 of 22 declared devices.

Catalogue references include 28001_L-kit, 28001_R-kit, 95001, 95007, 95008, 95009.

European nomenclature codes declared: V80, K0201010302, K0201010301, Q03010299, Z12020699, U08020501.

United States market access

FDA establishment registerRegistered with FDA
Matched entryVECMEDICAL SPAIN, S.L. (ES) · FDA 3011545739
Devices in EUDAMED22
Country of registrationSpain

Device-level evidence

Devices with a numeric GTIN22
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: United States only. VEC MEDICAL SPAIN, S.L. is registered in the United States but was not found in the Canadian register.

Notified body certificates

CertificateStatusExpiry
2025 CR 0056issued2030-07-06
2023 PR 0006issued2028-11-21

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