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Liquid-based Cytology Reagents

by Zhuhai Lituo Biotechnology Co., Ltd. 24 variants

Ref LTC040102Model 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

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697223584LBCR6 Basic UDI-DI 06972235844381UDI-DIDate15 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

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, LTC040102
Primary DI / UDI-DI
06972235844381
Basic UDI-DI
697223584LBCR6
EMDN Code
W01030799 Histology / cytology reagents - other
Device Class
Class A
EU market of registration
Türkiye

Manufacturer details

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

Other devices from Zhuhai Lituo Biotechnology Co., Ltd.

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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