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Smart Prep

by RM Life Science Co., Ltd. South Korea EUDAMED

Ref G002-0101

EMDN W0202059099

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number880031266G0023U Basic UDI-DIDate19 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Liquid-Based Cytology (LBC) System
Model / Reference
G002-0101
Primary DI / UDI-DI
08800312660341
Basic UDI-DI
880031266G0023U
Direct Marketing DI
08800312660341
EMDN Code
W0202059099 Various processing instruments for hystology / cytology - other
Device Class
Class A
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
KR-MF-000048522
Authorised representative
Javitech Consulting GmbH DE-AR-000045915

Other devices from RM Life Science Co., Ltd.

See all devices from RM Life Science 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 222f9e4e-ac1e-41af-9feb-470b0c47c52c 61 fields · synced 25 Oct 2026