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Liquid-based Cytology Smear Processor
EUDAMEDClass A (EU MDR)
Ref LTS-3000BModel LTS-3000A, LTS-3000B, LTS-3000BSRef LTS-3000A
Identity
- Trade Name
- Liquid-based Cytology Smear Processor EUDAMED
- Device Name
- Liquid-based Cytology Smear Processor EUDAMED
- Model / Reference
- LTS-3000B EUDAMEDLTS-3000A, LTS-3000B, LTS-3000BS EUDAMEDLTS-3000A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972129850474 EUDAMED06972129851969 EUDAMED
- Basic UDI-DI
- 6972129853000ABUD EUDAMED
- EMDN Code
- W0202059002 AUTOMATED SLIDE STAINERS EUDAMEDW0202059099 VARIOUS PROCESSING INSTRUMENTS FOR HYSTOLOGY / CYTOLOGY - 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
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Category: Microscope slide stainer IVD
Liquid-based Cytology Smear Processor by Hunan Lituo Biotechnology Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 6972129853000ABUD | 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 (3)
- EUDAMED 2da91146-1605-459b-8683-87e4dafc6889 61 fields · synced Aug 1, 2026
- EUDAMED d07cba5e-eb4a-42fe-a020-b9276101d645 61 fields · synced Jun 18, 2026
- EUDAMED d1e2acc5-b49a-4534-8c3c-f40a93c9a8f2 61 fields · synced Aug 1, 2026