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Raiden3

by KANEKA Corporation 75 variants

Ref RD3-30-250Model Kaneka PTCA Balloon Dilatation Catheters

Active European Union

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 25 Oct 2026. What this means

Overview

The Raiden3 medical device from Kaneka Corporation is a Class III FDA-approved balloon dilatation catheter designed for minimally invasive procedures. With its advanced technology and user-friendly design, this device is ideal for various applications in clinical settings.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-04540778149700 Basic UDI-DI 04540778149700UDI-DIDate15 Jul 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  • Withdrawn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/MDD Active

Specification

EUDAMED

Model / Reference
Kaneka PTCA Balloon Dilatation Catheters, RD3-30-250
Primary DI / UDI-DI
04540778149700
Basic UDI-DI
B-04540778149700
EMDN Code
C010401020101 Ptca balloon dilation catheters
Device Class
Class III
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
JP-MF-000022143
Authorised representative
Kaneka Medical Europe N.V. BE-AR-000010091

Other devices from Kaneka Corp.

See all devices from Kaneka Corp. →

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