EU → North America 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 IIb61
Class I166

Most frequent device types declared: NC xperience, capturer, iVolution pro, navitian, oceanus 14 RX.

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

Devices declared under this manufacturer

Showing 12 of 896 declared devices.

Catalogue references include BPPC18150300120, BPPC18150300150, BPPC18170600040, BPPC35080800020, BPPC35080900060, BPPC35140600060.

European nomenclature codes declared: C010402020101, P070402020102, C0104020299, C0104010299, C010401020101, C010401020501.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED896
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 GTIN896
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryLIFE VASCULAR DEVICES BIOTECH S.L.

What it holds in Canada

Licences on record8
Currently active0
Class 2 devices5
Class 4 devices3
First licensed2017-03-21

Licence types: Device Family (7), Device Group Family (1).

Licensed under: IVASCULAR LUMINOR 18, IVASCULAR LUMINOR 14M, PACLITAXEL ELUTING PTA , IVASCULAR OCEANUS, PTA BALLOON DILATATION CATH, IVASCULAR CAPTURER, THROMBUS EXTRACTION CATHET, IVASCULAR SERGEANT PERIPHERAL SUPPORT CATHETER, IVASCULAR NAVITIAN CORONARY MICROCATHETER.

North American profile: Canada only. Life Vascular Devices Biotech, S.L. holds a Canadian licence but was not found in the U.S. register.

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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