Identity
- Trade Name
- CALIBRATORE HDL/LDL EUDAMED
- Device Name
- CALIBRATORE HDL/LDL EUDAMED
- Model / Reference
- FCC40-1-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-CALIBRATORE-HDL-LDLND EUDAMED
- Basic UDI-DI
- B-CALIBRATORE-HDL-LDLND EUDAMED
- EMDN Code
- W0101050302 CALIBRATORS SINGLE COMPONENT (CC) EUDAMED
Classification
- Device Class
- Class IVD General 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
Calibratore Hdl/Ldl by Futurlab S.r.l. — 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-CALIBRATORE-HDL-LDLND | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Futurlab S.r.l.
- EUDAMED SRN
- IT-MF-000046539
Sources (1)
- EUDAMED 66ea6af3-0df6-4648-9ecc-7f2c7c11b3e0 61 fields · synced Jul 26, 2026