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Elisio

by Nipro Corporation EUDAMED

Active European Union

Ref ELI-17HX-GJ, ELI-19K-GJ, ELI-15K-GJ, ELI-21H-GC, ELI-17K-GJ, ELI-15M-GC, ELI-17L-GC, ELI-13M-PO-GJ, ELI-13M-PO-GC, ELI-19H-PO-GJ, ELI-17M-GC, ELI-19HX-GJ, ELI-21L-GC, ELI-13HX-GJ, ELI-11L-PO-GJ, ELI-19M-PO-GC, ELI-17H-GC, ELI-13L-GC, ELI-19H-PO-GC, ELI-17M-PO-GJ, ELI-21HX-GJ, ELI-13L-PO-GJ, ELI-21H-GJ, ELI-11M-PO-GJ, ELI-21M-PO-GC, ELI-17H-PO-GC, ELI-15L-PO-GC, ELI-19L-GC, ELI-13H-GJ, ELI-17L-PO-GJ, ELI-15M-GJ, ELI-17L-PO-GC, ELI-11H-PO-GJ, ELI-15H-PO-GC, ELI-25H-GJ, ELI-15H-PO-GJ, ELI-13M-GC, ELI-21K-GJ, ELI-21L-PO-GC, ELI-21H-PO-GJ, ELI-13H-GC, ELI-13L-GJ, ELI-17L-GJ, ELI-17M-GJ, ELI-17M-PO-GC, ELI-11H-GJ, ELI-13M-GJ

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number49684200TDA1011GM Basic UDI-DIDate6 Feb 2026RegisteredStatusActive

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  • Withdrawn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
Synthetic Hemodialyzer
Model / Reference
ELI-17HX-GJ, ELI-19K-GJ, ELI-15K-GJ, ELI-21H-GC, ELI-17K-GJ, ELI-15M-GC, ELI-17L-GC, ELI-13M-PO-GJ, ELI-13M-PO-GC, ELI-19H-PO-GJ, ELI-17M-GC, ELI-19HX-GJ, ELI-21L-GC, ELI-13HX-GJ, ELI-11L-PO-GJ, ELI-19M-PO-GC, ELI-17H-GC, ELI-13L-GC, ELI-19H-PO-GC, ELI-17M-PO-GJ, ELI-21HX-GJ, ELI-13L-PO-GJ, ELI-21H-GJ, ELI-11M-PO-GJ, ELI-21M-PO-GC, ELI-17H-PO-GC, ELI-15L-PO-GC, ELI-19L-GC, ELI-13H-GJ, ELI-17L-PO-GJ, ELI-15M-GJ, ELI-17L-PO-GC, ELI-11H-PO-GJ, ELI-15H-PO-GC, ELI-25H-GJ, ELI-15H-PO-GJ, ELI-13M-GC, ELI-21K-GJ, ELI-21L-PO-GC, ELI-21H-PO-GJ, ELI-13H-GC, ELI-13L-GJ, ELI-17L-GJ, ELI-17M-GJ, ELI-17M-PO-GC, ELI-11H-GJ, ELI-13M-GJ
Primary DI / UDI-DI
05420040813869, 05420040803600, 05420040803587, 04968420722673, 05420040803594, 04968420722703, 04968420728699, 05420040810356, 04968420728798, 05420040810318, 04968420722710, 05420040813876, 04968420728712, 05420040813845, 05420040810462, 04968420728828, 04968420722659, 04968420728675, 04968420728767, 05420040810370, 05420040813883, 05420040810479, 05420040801330, 05420040810349, 04968420728835, 04968420728750, 04968420729917, 04968420728705, 05420040801293, 05420040810493, 05420040801385, 04968420729924, 05420040810271, 04968420728743, 05420040801347, 05420040810295, 04968420722697, 05420040803617, 04968420729948, 05420040810325, 04968420722635, 05420040808223, 05420040808247, 05420040801392, 04968420728811, 05420040801286, 05420040801378
Basic UDI-DI
49684200TDA1011GM, 4968420TDHE1011XW
EMDN Code
F01060303, F01060203, F01060103
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

  • 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