EU → US Device Access

Life Vascular Devices Biotech, S.L.

ES-MF-000019783 · Spain · Sant Vicenç dels Horts

Life Vascular Devices Biotech, S.L. is registered in the European database on medical devices as a manufacturer, with 896 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa669
Class I166
Class IIb61

Most frequent device types declared: oceanus 18, oceanus 35, oceanus 14pro, NC xperience, xperience pro.

Among these devices, 896 are declared sterile, 61 implantable.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED896
Country of registrationSpain
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

Notified body certificates

CertificateStatusExpiry
G10 103542 0002issued2028-02-23
2026 DR 0092issued2028-12-21
2025 DR 0049issued2028-12-21
2025 DR 0046issued2028-12-21
2024 DR 0039issued2028-12-21
2024 DR 0018issued2028-12-21
2023 CR 0011supplemented2028-12-21

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