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Lateral Flow Immunoassay Analyzer
EUDAMEDClass A (EU MDR)
Ref 0120303Model FA-160
Identity
- Trade Name
- Lateral Flow Immunoassay Analyzer EUDAMED
- Device Name
- Lateral Flow Immunoassay Analyzer EUDAMED
- Model / Reference
- FA-160 EUDAMED0120303 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970341681500 EUDAMED
- Basic UDI-DI
- 6970341680120302GX EUDAMED
- EMDN Code
- W0201069099 VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands 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
Lateral Flow Immunoassay Analyzer by Shenzhen Lifotronic Technology 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 | 6970341680120302GX | Class A | Active |
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Manufacturer
- Manufacturer
- Shenzhen Lifotronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005654
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (1)
- EUDAMED e8331be1-26ba-4b3a-9209-ceb299c7d589 61 fields · synced Jul 13, 2026