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Liquid-based Cytology Reagents

by Zhuhai Lituo Biotechnology Co., Ltd. China EUDAMED

Ref LTC020104Model Type I：GYN、Non-GYN；Type Ⅱ：GYN、Non-GYN；Type Ⅲ：GYN、Non-GYN；Type IV：GYN、Non-GYN；Type Ⅴ：GYN、Non-GYN；Type Ⅶ：GYN、Non-GYN

EMDN W01030799

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697223584LBCR6 Basic UDI-DIDate15 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
Type I：GYN、Non-GYN；Type Ⅱ：GYN、Non-GYN；Type Ⅲ：GYN、Non-GYN；Type IV：GYN、Non-GYN；Type Ⅴ：GYN、Non-GYN；Type Ⅶ：GYN、Non-GYN, LTC020104
Primary DI / UDI-DI
06972235844329
Basic UDI-DI
697223584LBCR6
EMDN Code
W01030799 Histology / cytology reagents - other
Device Class
Class A
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000026852
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

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 5d55994f-52bc-4838-818c-5460494b08d3 61 fields · synced 24 Oct 2026