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Dry Fluorescence Immunoassay Analyzer
EUDAMEDClass A (EU MDR)
Ref L4-4000Model LS-4000Ref L5-1100Model LS-1100Ref L6-2100Model LS-2100
Identity
- Device Name
- Dry Fluorescence Immunoassay Analyzer EUDAMED
- Model / Reference
- LS-4000 EUDAMEDL4-4000 EUDAMEDLS-1100 EUDAMEDL5-1100 EUDAMEDLS-2100 EUDAMEDL6-2100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971763224009 EUDAMED06971763229059 EUDAMED06971763229066 EUDAMED
- Basic UDI-DI
- 69717632248014001QZ EUDAMED69717632247057001SH EUDAMED69717632247057002SK EUDAMED
- Direct Marketing DI
- 06971763224009 EUDAMED06971763229059 EUDAMED06971763229066 EUDAMED
- EMDN Code
- W0299 IVD INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy 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
Dry Fluorescence Immunoassay Analyzer by Lansion 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 | 69717632248014001QZ | Class A | Active |
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Manufacturer
- Manufacturer
- Lansion Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000001086
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (3)
- EUDAMED 311721d1-8162-4fd6-bde0-e93514b57d67 61 fields · synced Jul 18, 2026
- EUDAMED 9dc5b139-803a-4477-bfed-460bba5d98a1 61 fields · synced May 17, 2026
- EUDAMED a05e60cd-4fc7-43b4-be4a-a4b9e4471a59 61 fields · synced May 18, 2026