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Liquid-based Cytology Reagents

by Hunan Lituo Biotechnology Co., Ltd. 12 variants

Ref LTC020101Model 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；

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697212985LBCRMR Basic UDI-DI 06972129850092UDI-DIDate30 Jul 2024RegisteredStatusActive

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  • Withdrawn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；, LTC020101
Primary DI / UDI-DI
06972129850092
Basic UDI-DI
697212985LBCRMR
EMDN Code
W01030799 Histology / cytology reagents - other
Device Class
Class A
EU 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

  • 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