Identity
- Trade Name
- SP 5 Fractions CF/50 EUDAMED
- Device Name
- Serum protein separation reagent kit EUDAMED
- Model / Reference
- SP KIT EUDAMEDFE051NZ-5KIT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 80588943001804 EUDAMED
- Basic UDI-DI
- 805889430FENZLV EUDAMED
- EMDN Code
- W01010235 PROTEIN ELECTROPORESIS 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
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
Yes
EUDAMED
SP 5 Fractions CF/50 by Futurlab S.r.l. — 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 | 805889430FENZLV | Class A | Active |
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Manufacturer
- Manufacturer
- Futurlab S.r.l.
- EUDAMED SRN
- IT-MF-000046539
Sources (1)
- EUDAMED 51196caf-3202-420d-b314-a60ca808f950 61 fields · synced Jul 13, 2026