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iVascular iVolution pro

by Life Vascular Devices Biotech, S.L. 61 variants

Ref SPNBC35N080060200Model iVolution pro

Active European Union

CE MDR

Valid until

21 Dec 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number84353873ivolutionproF8 Basic UDI-DI 08435387316055UDI-DIDate20 May 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2024 DR 0018 Active

    Technical documentation EU MDR

    Certifier
    CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS 0318
    Issued
    1 Mar 2024
    Expires
    21 Dec 2028

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
iVolution pro, SPNBC35N080060200
Primary DI / UDI-DI
08435387316055
Basic UDI-DI
84353873ivolutionproF8
Direct Marketing DI
08435387316055
EMDN Code
P070402020102 Non-stainless steel peripheral vascular bare metal stents
Device Class
Class IIb
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000019783

Other devices from Life Vascular Devices Biotech, S.L.

See all devices from Life Vascular Devices Biotech, S.L. →

Properties

  • Sterile
  • Implantable

Other properties (12)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Sutures: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No