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Accusol

by NorrDia Belgium bv Belgium EUDAMED

Ref RPE04

EMDN F0499

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-19349285000991 Basic UDI-DIDate28 Apr 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 24 Oct 2026

Device Name
Accusol K+4
Model / Reference
RPE04
Primary DI / UDI-DI
19349285000991
Basic UDI-DI
B-19349285000991
EMDN Code
F0499 Dialysis concentrates - other
Device Class
Class IIb
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
BE-MF-000003701

Other devices from NorrDia Belgium bv

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (10)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 82f1ab25-bb14-4392-ae55-9dcefac340ce 61 fields · synced 24 Oct 2026