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Shockwave C2 Aero Fly Coronary Intravascular Lithotripsy (IVL) Catheter

by Shockwave Medical Inc. 4 variants

Ref C2AFIVLIP4012

Expiring European Union

CE MDR

Valid until

17 Aug 2027

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number00195451C2AFIVLIPBS Basic UDI-DI 00195451001192UDI-DIDate28 Aug 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 728474 Expiring Supplemented Expires in 289 days

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    22 Jun 2026
    Expires
    17 Aug 2027
    Reason
    Add device or group

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Expiring

Specification

EUDAMED

Model / Reference
C2AFIVLIP4012
Primary DI / UDI-DI
00195451001192
Basic UDI-DI
00195451C2AFIVLIPBS
EMDN Code
C01040199 Cardiac angiography devices - other
Device Class
Class III
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000012770
Authorised representative
ICON (LR) Limited IE-AR-000006507

From the manufacturer

Manufacturer's product page: IVL for Coronary Artery Disease

Other devices from Shockwave Medical Inc.

See all devices from Shockwave Medical Inc. →

Properties

  • Sterile

Other properties (12)

  • Implantable: No
  • 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