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Fb

by Nipro Corporation Japan EUDAMED

Ref FB 15U-GJ

EMDN F01060202

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number49684200TDA1021GQ Basic UDI-DIDate6 Feb 2026RegisteredStatusActive

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
Hemodialyzer
Model / Reference
FB 15U-GJ
Primary DI / UDI-DI
05420040801965
Basic UDI-DI
49684200TDA1021GQ
EMDN Code
F01060202 DIALYSERS - UFC = 18 - 35 ml/h/mmHg, SUBSTITUTED CELLULOSE MEMBRANES
Device Class
Class IIb
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
JP-MF-000026759
Authorised representative
Nipro Medical Europe NV BE-AR-000022416

Other devices from Nipro Corporation

See all devices from Nipro Corporation →

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 7dfc1657-49f9-4ef0-9335-78ded656f32e 61 fields · synced 22 Oct 2026