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Liquid-based Cytology Reagents
EUDAMEDClass A (EU MDR)
Ref LTC030107Model 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；
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； EUDAMEDLTC030107 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972129850788 EUDAMED
- Basic UDI-DI
- 697212985LBCRMR 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 (1)
- EUDAMED 21de07ae-5ad5-452d-8f6b-538fe756e0f2 61 fields · synced Jun 18, 2026