Identity
- Trade Name
- i-ImmunDx Analyzer EUDAMED
- Device Name
- i-ImmunDx Analyzer EUDAMED
- Model / Reference
- S03A EUDAMEDS03A-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972976460031 EUDAMED
- Basic UDI-DI
- B-06972976460031 EUDAMED
- EMDN Code
- W0201069099 VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - 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
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
i-ImmunDx Analyzer 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-06972976460031 | 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 (1)
- EUDAMED 0c166ca3-568b-4b41-bb3a-55bfbf8d824b 61 fields · synced Jun 19, 2026