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Dialyzer (Dialysis Filter medium flux)

by Poly Medicure Limited EUDAMED

Active European Union

Ref 90438Model Dialyzer (Dialysis Filter medium flux)

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number890209590371GU Basic UDI-DIDate17 Aug 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Dialyzer (Dialysis Filter)
Model / Reference
Dialyzer (Dialysis Filter medium flux), 90438
Primary DI / UDI-DI
08902095904381
Basic UDI-DI
890209590371GU
EMDN Code
F01060203 DIALYSERS - UFC = 18 - 35 ml/h/mmHg, SYNTHETIC MEMBRANES
Device Class
Class IIb
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
IN-MF-000043011
Authorised representative
Obelis s.a. BE-AR-000000106

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Properties

  • 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