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Smart-ISH Solve

by Oacp Ie Ltd Ireland EUDAMED

Ref 200175Model Smart-ISH Solve

EMDN W01030703

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number539154038200175G9 Basic UDI-DIDate5 May 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
Smart-ISH Solve
Model / Reference
Smart-ISH Solve, 200175
Primary DI / UDI-DI
53915403800626
Basic UDI-DI
539154038200175G9
Direct Marketing DI
53915403800626
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
  • 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

Sources (1)

  • EUDAMED 3f60ae17-f286-4939-b095-3d5d75b090a6 61 fields · synced 22 Oct 2026