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Automatic Immunofluoresecence Quantitative Analyzer
EUDAMEDClass A (EU MDR)
Ref LTS-IF160Model LTS-IF160, LTS-IF80, LTS-IF10
Identity
- Trade Name
- Automatic Immunofluoresecence Quantitative Analyzer EUDAMED
- Device Name
- Immunofluoresecence Quantitative Analyzer EUDAMED
- Model / Reference
- LTS-IF160, LTS-IF80, LTS-IF10 EUDAMEDLTS-IF160 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972129852119 EUDAMED
- Basic UDI-DI
- 697212985IF22 EUDAMED
- EMDN Code
- W02010199 CHEMISTRY INSTRUMENTS - 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
Automatic Immunofluoresecence Quantitative Analyzer 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 | 697212985IF22 | 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 10022058-aeca-432a-877a-33ac68d95bac 61 fields · synced Jun 19, 2026