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Fluorescent Immunoassay Analyzer
EUDAMEDClass A (EU MDR)
Ref LYOFIA8Ref LYOFIA-I
Identity
- Device Name
- Fluorescent Immunoassay Analyzer EUDAMED
- Model / Reference
- LYOFIA8 EUDAMEDLYOFIA-I EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975391230135 EUDAMED06975391230128 EUDAMED
- Basic UDI-DI
- 697539123LYOFIA-IMF EUDAMED
- EMDN Code
- W0299 IVD INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain 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
Fluorescent Immunoassay Analyzer by Hunan Kangxin 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 | 697539123LYOFIA-IMF | Class A | Active |
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Manufacturer
- Manufacturer
- Hunan Kangxin Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000020121
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 0a5d0201-2133-4daf-865e-326af56bdf5d 61 fields · synced Jul 14, 2026
- EUDAMED 2f0b13c1-8e94-45c3-a195-29ac51afc6bd 61 fields · synced May 18, 2026