Identity
- Trade Name
- MFC EUDAMED
- Device Name
- Micro-Capillary Fluid Collector (MFC) EUDAMED
- Model / Reference
- S04A2.2, S04E1.1 EUDAMEDS04A2.2-050 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972976461069 EUDAMED
- Basic UDI-DI
- 697297646S04VJ EUDAMED
- EMDN Code
- W05019099 SAMPLES COLLECTION DEVICES - 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Mfc by Seinda Biomedical Corporation — 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 | 697297646S04VJ | Class A | 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 f45b1b4f-6325-4306-bc41-f6abe5e7eb62 61 fields · synced Jun 18, 2026