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Liquid-based Cytology Reagents
EUDAMEDClass 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
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; EUDAMEDLTC030101 EUDAMEDLTC040102 EUDAMEDLTC020104 EUDAMEDLTC030105 EUDAMEDLTC040104 EUDAMEDLTC010103 EUDAMEDLTC020102 EUDAMEDLTC090102 EUDAMEDLTC090104 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972129850153 EUDAMED06972129850177 EUDAMED06972129850757 EUDAMED06972129850771 EUDAMED06972129850184 EUDAMED06972129851983 EUDAMED06972129850146 EUDAMED06972129850191 EUDAMED06972129850207 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697212985LBCRMR | Class A | Active |
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Manufacturer
- Manufacturer
- Hunan Lituo Biotechnology Co., Ltd.
- 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