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Liquid-based cytology slide processing kit (PAP)

by Tianjin Bai Lixin Bio-tech Co., Ltd. EUDAMED

Active European Union

Ref K-3100Model GG, CGG, GN, 620S, 320G, 320NG, 320S

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697498683K3100LW Basic UDI-DIDate18 Apr 2025RegisteredStatusActive

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  • Withdrawn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

Model / Reference
GG, CGG, GN, 620S, 320G, 320NG, 320S, K-3100
Primary DI / UDI-DI
06974986838381
Basic UDI-DI
697498683K3100LW
Direct Marketing DI
06974986838381
EMDN Code
W01030799,W0202059085
Device Class
Class A
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
CN-MF-000040961
Authorised representative
Kingsmead Service B.V. NL-AR-000002066

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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