Identity
- Trade Name
- FC20 Plus EUDAMED
- Device Name
- FCseries Clinical Chemistry Analyzer EUDAMED
- Model / Reference
- FCseries EUDAMEDFC20 Plus EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08058894300036 EUDAMED
- Basic UDI-DI
- 80588943000368J EUDAMED
- EMDN Code
- W0201010101 CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400) 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
Yes
EUDAMED
New Device
Yes
EUDAMED
FC20 Plus 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 | 80588943000368J | Class A | Active |
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Manufacturer
- Manufacturer
- Futurlab S.r.l.
- EUDAMED SRN
- IT-MF-000046539
Sources (1)
- EUDAMED 136f968d-d32d-42e8-b47f-04ae250aa913 61 fields · synced Jun 18, 2026