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Raiden3

by KANEKA Corporation Japan EUDAMED

Ref RD3-18-225Model Kaneka PTCA Balloon Dilatation Catheters

EMDN C010401020101

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-04540778149564 Basic UDI-DIDate9 Feb 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
Kaneka PTCA Balloon Dilatation Catheters, RD3-18-225
Primary DI / UDI-DI
04540778149564
Basic UDI-DI
B-04540778149564
EMDN Code
C010401020101 Ptca balloon dilation catheters
Device Class
Class III
Market of Registration
Germany

Manufacturer details

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

Related devices

Category: Coronary angioplasty balloon catheter, cutting/scoring

Other devices from KANEKA Corporation

See all devices from KANEKA Corporation →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 87ff1d9e-49e7-43eb-ac38-344cb61ace62 61 fields · synced 22 Oct 2026