Identity
- Trade Name
- LTA-POC EUDAMED
- Device Name
- Lymphotoxin-α Test Kit (LTA POC) EUDAMED
- Model / Reference
- S02B EUDAMEDS02B-020, S02B-050 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972976463032 EUDAMED
- Basic UDI-DI
- B-06972976463032 EUDAMED
- EMDN Code
- W01021699 RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Lta-Poc by Seinda Biomedical Corporation — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06972976463032 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Seinda Biomedical Corporation
- EUDAMED SRN
- CN-MF-000047055
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (2)
- EUDAMED 4e2a9106-0a4a-486b-915f-7dccdc2bc319 61 fields · synced Jul 9, 2026
- EUDAMED 4e2a9106-0a4a-486b-915f-7dccdc2bc319-1 61 fields · synced Jun 10, 2026