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Cell preservative solution
EUDAMEDClass A (EU MDR)
Ref LTC170111Model Model I, Model II
Identity
- Trade Name
- Cell preservative solution EUDAMED
- Device Name
- Cell Preservative Solution EUDAMED
- Model / Reference
- Model I, Model II EUDAMEDLTC170111 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16972129850303 EUDAMED
- Basic UDI-DI
- 697212985CPSSS EUDAMED
- Direct Marketing DI
- 16972129850303 EUDAMED
- EMDN Code
- W01030705 FIXING REAGENTS (HISTOLOGY/CYTOLOGY) EUDAMED
Classification
- Device Class
- Class A 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
Cell preservative solution 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 | 697212985CPSSS | 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 a97885ff-99b3-4e7e-b116-8aa1c8f71f6e 61 fields · synced Jun 17, 2026