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Liquid-based cytology slide processing kit

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

Active European Union

Ref K-1000

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697498683K1000LB Basic UDI-DIDate28 May 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  • Withdrawn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
K-1000
Primary DI / UDI-DI
06974986838428
Basic UDI-DI
697498683K1000LB
Direct Marketing DI
06974986838428
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

Show 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