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HEMATOLOGY CONTROL for reticulocyte MK-RE3

by Nihon Kohden Corporation 2 variants

Ref RE304

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number4931921IVD0012NQ Basic UDI-DI 04931921015452UDI-DIDate22 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Control Blood Multilevel
Model / Reference
RE304
Primary DI / UDI-DI
04931921015452
Basic UDI-DI
4931921IVD0012NQ
EMDN Code
W0103010503 Multilevel blood controls
Device Class
Class B
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
JP-MF-000019022
Authorised representative
NIHON KOHDEN EUROPE GmbH DE-AR-000010740

Other devices from Nihon Kohden Corporation

See all devices from Nihon Kohden Corporation →

Properties

  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No