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Accusol

by NorrDia Belgium bv Belgium EUDAMED

Ref RPE00, RPE02

EMDN F0499

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-19349285000977 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 22 Oct 2026

Device Name
Accusol K+0
Accusol K+2
Model / Reference
RPE00, RPE02
Primary DI / UDI-DI
19349285000977, 19349285000984
Basic UDI-DI
B-19349285000977, B-19349285000984
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 (2)

  • EUDAMED ff60c9c6-38ff-40ba-abcb-324180cfd314 61 fields · synced 22 Oct 2026
  • EUDAMED 19349285000984|B-19349285000984 61 fields · synced 28 Jul 2026