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Shockwave M5+ Peripheral Intravascular Lithotripsy (IVL) Catheter

by Shockwave Medical Inc. 9 variants

Ref M5PIVLIP6060

Active European Union

CE MDR CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-00195451000942 Basic UDI-DI 00195451000942UDI-DIDate9 Oct 2026RegisteredStatusActive
European UnionCE/MDD NumberB-00195451000942 Basic UDI-DI 00195451000942UDI-DIDate9 Oct 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR, CE/MDD Active

Specification

EUDAMED

Model / Reference
M5PIVLIP6060
Primary DI / UDI-DI
00195451000942
Basic UDI-DI
B-00195451000942, 0195451M5PIVLLN
EMDN Code
C01040299 Peripheral angiography devices - other
Device Class
Class IIb
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 Peripheral 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