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Aorfix™ AAA Endovascular Stent Graft with Intelliflex™ Low Profile Delivery System

by Lombard Medical Limited 493 variants

Ref MB-28-111-80-18

Active European Union

CE MDR

Valid until

20 Dec 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier DQS Medizinprodukte GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Overview

The Aorfix AAA Endovascular Stent Graft with Intelliflex Low Profile Delivery System is a cutting-edge medical device designed for minimally invasive endovascular procedures. Featuring an innovative Intelliflex low profile delivery system, this stent graft provides superior patency rates and reduced complications compared to traditional stents.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number05055715AO01BU Basic UDI-DI 05055715634540UDI-DIDate11 Apr 2024RegisteredStatusActive

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 170781682 Active

    Quality management system EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    21 Dec 2023
    Expires
    20 Dec 2028
  • 170781685 Active

    Technical documentation EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    21 Dec 2023
    Expires
    20 Dec 2028

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
MB-28-111-80-18
Primary DI / UDI-DI
05055715634540
Basic UDI-DI
05055715AO01BU, B-05055715634540
EMDN Code
C019009 Aortic occlusion systems
Device Class
Class III
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
GB-MF-000014515
Authorised representative
Medical Device Management Ltd IE-AR-000002496

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Properties

  • Sterile
  • Implantable

Other properties (11)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: 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