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N-Histofine Simple Stain AEC Solution

by Nichirei Biosciences Inc. EUDAMED

Active European Union

Ref 435181F

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number4987780ancillariesA4X Basic UDI-DIDate1 Jun 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
N-Histofine
Model / Reference
435181F
Primary DI / UDI-DI
04987780861488
Basic UDI-DI
4987780ancillariesA4X
Direct Marketing DI
04987780861488
EMDN Code
W01030708 Stain solutions (histology/cytology)
Device Class
Class A
Market of Registration
Czechia

Manufacturer details

EUDAMED SRN
JP-MF-000027151
Authorised representative
MedEnvoy Global BV NL-AR-000024028

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Properties

  • Reagent
  • Professional Testing

Other properties (9)

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