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Rapid ISH Integra Plus

by Oacp Ie Ltd EUDAMED

Active European Union

Ref 031114-MOModel Rapid ISH Integra Plus

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number539154038031114-MOBQ Basic UDI-DIDate5 May 2022RegisteredStatusActive

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  • Withdrawn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
Rapid ISH Integra Plus
Model / Reference
Rapid ISH Integra Plus, 031114-MO
Primary DI / UDI-DI
53915403800312
Basic UDI-DI
539154038031114-MOBQ
Direct Marketing DI
53915403800312
EMDN Code
W01030703 DNA in situ hybridisation reagents
Device Class
Class A
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
IE-MF-000003506

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Properties

Show 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