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Surdial X

by Nipro Corporation Japan EUDAMED

Ref Type A 230VModel Surdial X

EMDN Z12090201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-04968420514957 Basic UDI-DIDate7 Aug 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
Single Patient Dialysis Machine
Model / Reference
Surdial X, Type A 230V
Primary DI / UDI-DI
04968420514957
Basic UDI-DI
B-04968420514957
EMDN Code
Z12090201 Haemodialysis equipment
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 Company, Ltd.

See all devices from Nipro Company, Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (12)
  • Sterile: No
  • 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
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 04968420514957|B-04968420514957 61 fields · synced 24 Oct 2026