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Ed Coil

by KANEKA Corporation Japan EUDAMED

Ref 353-1610RS

EMDN C010402020301

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-04540778165878 Basic UDI-DIDate25 Dec 2025RegisteredStatusActive

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
353-1610RS
Primary DI / UDI-DI
04540778165878
Basic UDI-DI
B-04540778165878
EMDN Code
C010402020301 Embolisation coils
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

Other devices from KANEKA Corporation

See all devices from KANEKA Corporation →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
Other properties (11)
  • 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 311eaa7b-7aa0-4cdd-a066-3525ed7c29c9 61 fields · synced 22 Oct 2026