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NEO Iris

by IMMUCOR Medizinische Diagnostik GmbH Germany EUDAMED

Ref 0064598

EMDN W0202030102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number88823405W0202030102A52HY Basic UDI-DIDate15 Jun 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Galileo NEO / NEO Iris
Model / Reference
0064598
Primary DI / UDI-DI
10888234301417, 04042091000671
Basic UDI-DI
88823405W0202030102A52HY, 40420910000S3C
Direct Marketing DI
10888234301417
04042091000671
EMDN Code
W0202030102 Automated blood grouping analysers
Device Class
Class A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000006494

From the manufacturer

Manufacturer's product page: NEO Iris®

Other devices from IMMUCOR Medizinische Diagnostik GmbH

See all devices from IMMUCOR Medizinische Diagnostik GmbH →

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
  • Surgical Instrument
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No

Sources (2)

  • EUDAMED 5ebec853-719e-452a-b616-b732aeca8c86 61 fields · synced 22 Oct 2026
  • EUDAMED 04042091000671|40420910000S3C 61 fields · synced 19 May 2026