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STEALTH 360™ Peripheral Orbital Atherectomy System

by Cardiovascular Systems, Inc. EUDAMED

Active European Union

Ref P-2ST-SO150-145

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-10850000491462 Basic UDI-DIDate16 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

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.

Specification

EUDAMED

Device Name
Peripheral Orbital Atherectomy System
Model / Reference
P-2ST-SO150-145
Primary DI / UDI-DI
10850000491462
Basic UDI-DI
B-10850000491462
EMDN Code
C010402020602 Peripheral atherectomy systems, rotational
Device Class
Class IIa
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000047663
Authorised representative
ICON (LR) Limited IE-AR-000006507

Other devices from Cardiovascular Systems, Inc.

See all devices from Cardiovascular Systems, 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