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RöKo-Filling-Line 1

by CARDEA GmbH & Co. KG Germany EUDAMED

Ref rkp-FL-1

EMDN Z11050185

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number426059063000002AA Basic UDI-DIDate16 Feb 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
Kontrastmittel-Applikations-Set 12h
Model / Reference
rkp-FL-1
Primary DI / UDI-DI
04260590630032
Basic UDI-DI
426059063000002AA
EMDN Code
Z11050185 Magnetic resonance (mr) systems - consumables
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000006460

Other devices from CARDEA GmbH & Co. KG

See all devices from CARDEA GmbH & Co. KG →

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 fc4370e6-ab76-44f3-bad1-8164f124c078 61 fields · synced 22 Oct 2026