Identity
- Trade Name
- SYSTEMIC SOLUTION LR EUDAMED
- Device Name
- FUTURLAB-WASH-SOLUTIONS EUDAMED
- Model / Reference
- FCC80-1-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 80588943000814 EUDAMED
- Basic UDI-DI
- 80588943000438F EUDAMED
- EMDN Code
- W01019001 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC) 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
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
Yes
EUDAMED
Systemic Solution Lr 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 | 80588943000438F | Class A | Active |
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Manufacturer
- Manufacturer
- Futurlab S.r.l.
- EUDAMED SRN
- IT-MF-000046539
Sources (1)
- EUDAMED bc1d2301-7a81-410c-a786-26841743b8ea 61 fields · synced Jul 9, 2026