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Procedure pack KME

by Kaneka Medical Europe N.V. Belgium EUDAMED

Ref SET63 B

EMDN Z12170402

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5430003353APHERESEAB Basic UDI-DIDate9 Oct 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Procedure pack KME
Model / Reference
SET63 B
Primary DI / UDI-DI
05430003353301
Basic UDI-DI
5430003353APHERESEAB
EMDN Code
Z12170402 Therapeutic apheresis equipment
Device Class
Class IIb
Medical Purpose
Code Z12170402 THERAPEUTIC APHERESIS EQUIPMENT

Manufacturer details

EUDAMED SRN
BE-PR-000019754

Other devices from Kaneka Medical Europe N.V.

See all devices from Kaneka Medical Europe N.V. →

Properties & raw data

Show properties, registry sources and raw records
Other properties (1)
  • Sterile: No

Sources (1)

  • EUDAMED 35810b79-18b0-4779-bb2b-10763a1c036f 61 fields · synced 22 Oct 2026