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Kit de Prueba de Inmunoglobulina E (IgE POC)
EUDAMEDClass IVD General (EU MDR)
Ref S06B-020, S06B-050Model S06B
Identity
- Trade Name
- Kit de Prueba de Inmunoglobulina E (IgE POC) EUDAMED
- Model / Reference
- S06B EUDAMEDS06B-020, S06B-050 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972976463261 EUDAMED
- Basic UDI-DI
- B-06972976463261 EUDAMED
- EMDN Code
- W01020201 IMMUNOGLOBULIN E - TOTAL EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain 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
Kit de Prueba de Inmunoglobulina E (IgE 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-06972976463261 | 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 b8754f0f-aaae-4e28-9ba0-6c7007663b3c-1 61 fields · synced Jul 11, 2026
- EUDAMED b8754f0f-aaae-4e28-9ba0-6c7007663b3c-2 61 fields · synced Jul 11, 2026