Skip to content

Rapid-ISH Hemato

by Oacp Ie Ltd Ireland EUDAMED

Ref 031114-HEModel Rapid-ISH Hemato EMDN W01030703

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number539154038031114-HEAM 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  • Withdrawn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 · synced 22 Oct 2026

Device Name
Rapid-ISH Hemato
Model / Reference
Rapid-ISH Hemato, 031114-HE
Primary DI / UDI-DI
53915403800558
Basic UDI-DI
539154038031114-HEAM
Direct Marketing DI
53915403800558
EMDN Code
W01030703 DNA in situ hybridisation reagents
Device Class
Class A
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
IE-MF-000003506

Other devices from Oacp Ie Ltd

See all devices from Oacp Ie Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 9a4d143b-bd75-405e-a17c-3ae1111422fd 61 fields · synced 22 Oct 2026