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Liquid-based Cytology Reagents

by Hunan Lituo Biotechnology Co., Ltd. China EUDAMED

Ref LTC010102Model 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； EMDN W01030799

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697212985LBCRMR Basic UDI-DIDate30 Jul 2024RegisteredStatusActive

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  • Withdrawn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 · synced 25 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；, LTC010102
Primary DI / UDI-DI
06972129850023
Basic UDI-DI
697212985LBCRMR
EMDN Code
W01030799 Histology / cytology reagents - other
Device Class
Class A
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000029972
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Hunan Lituo Biotechnology Co., Ltd.

See all devices from Hunan Lituo Biotechnology Co., Ltd. →

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 1fe11d66-216e-41e8-9f11-72a09d5748e5 61 fields · synced 25 Oct 2026