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I-PREP2

by Imedikers Co., Ltd. South Korea EUDAMED

Ref Liquid Based Cytology System I-PREP USER MANUAL Ver.01

EMDN W02039004

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number880031799IP01DY Basic UDI-DIDate27 May 2025RegisteredStatusActive

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
I-PREP LBC Processor
Model / Reference
Liquid Based Cytology System I-PREP USER MANUAL Ver.01
Primary DI / UDI-DI
08800317990009
Basic UDI-DI
880031799IP01DY
Direct Marketing DI
08800317990009
EMDN Code
W02039004 Automated slide preparation units
Device Class
Class A
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
KR-MF-000047937
Authorised representative
Veritas Eston OÜ EE-AR-000046695

Other devices from Imedikers Co., Ltd.

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
  • Surgical Instrument
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No

Sources (1)

  • EUDAMED b6dfccf4-aacd-435d-a7fd-844f3800984a 61 fields · synced 22 Oct 2026