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Aquamax

by NorrDia Belgium bv Belgium EUDAMED

Ref HF12

EMDN F01060303

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-19349285000267 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

Model / Reference
HF12
Primary DI / UDI-DI
19349285000267
Basic UDI-DI
B-19349285000267
EMDN Code
F01060303 DIALYSERS - UFC > 35 ml/h/mmHg, SYNTHETIC MEMBRANES
Device Class
Class IIb
Market of Registration
Italy

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 fbf8ec78-dde4-47c7-a3d1-fe930c91def3 61 fields · synced 22 Oct 2026