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OAS Pump

by Cardiovascular Systems, Inc. EUDAMED 3 variants

Active European Union

Ref SIP-3000

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-10850000491059 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  • Withdrawn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
Pump
Model / Reference
SIP-3000
Primary DI / UDI-DI
10850000491059
Basic UDI-DI
B-10850000491059
EMDN Code
C010402020602 Peripheral atherectomy systems, rotational
Device Class
Class IIb
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

Other properties (13)

  • Sterile: No
  • 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