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Liquid-based Cytology Reagents

EUDAMED

Class A (EU MDR)

Ref LTC030101Model 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;Ref LTC040102Ref LTC020104Ref LTC030105Ref LTC040104Ref LTC010103Ref LTC020102Ref LTC090102Ref LTC090104

by Hunan Lituo Biotechnology Co., Ltd.

Identity

Trade Name
Liquid-based Cytology Reagents EUDAMED
Device Name
Liquid-based Cytology Reagents 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; EUDAMED
LTC030101 EUDAMED
LTC040102 EUDAMED
LTC020104 EUDAMED
LTC030105 EUDAMED
LTC040104 EUDAMED
LTC010103 EUDAMED
LTC020102 EUDAMED
LTC090102 EUDAMED
LTC090104 EUDAMED

Identifiers

Primary DI / UDI-DI
06972129850153 EUDAMED
06972129850177 EUDAMED
06972129850757 EUDAMED
06972129850771 EUDAMED
06972129850184 EUDAMED
06972129851983 EUDAMED
06972129850146 EUDAMED
06972129850191 EUDAMED
06972129850207 EUDAMED
Basic UDI-DI
697212985LBCRMR EUDAMED
Direct Marketing DI
06972129850153 EUDAMED
EMDN Code
W01030799 HISTOLOGY / CYTOLOGY REAGENTS - OTHER EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Türkiye EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

Liquid-based Cytology Reagents by Hunan Lituo Biotechnology Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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Manufacturer

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

Sources (9)

  • EUDAMED 44360c10-40a8-43d0-80ed-fb48a9b66b28 61 fields · synced Oct 6, 2026
  • EUDAMED 6339543a-7c47-4625-9830-e1883a66ac36 61 fields · synced Jul 10, 2026
  • EUDAMED d4998c9c-3696-44fc-a3bc-2ce944c40e11 61 fields · synced Jul 12, 2026
  • EUDAMED e8b6f854-5e31-442d-a3ef-b146c6b319ed 61 fields · synced Jul 20, 2026
  • EUDAMED e9f8d49e-b3df-420c-bdb5-f7dc3d0d3beb 61 fields · synced Jul 25, 2026
  • EUDAMED 179ad4c3-91e5-4317-b829-e2aab64ad524 61 fields · synced Jul 26, 2026
  • EUDAMED 5b510faa-b7de-4e96-9b2a-fde364deaa4b 61 fields · synced Jul 26, 2026
  • EUDAMED 8f971e86-1729-457a-b5e8-ab4ead9c4b87 61 fields · synced Jul 31, 2026
  • EUDAMED 0e6d6c70-89c7-4a7a-8ba4-ae38d421282a 61 fields · synced Aug 3, 2026