Identity
- Trade Name
- SG Calibrator Set EUDAMED
- Device Name
- SG Calibrator Set EUDAMED
- Model / Reference
- Reagent EUDAMED31111 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-31111EY EUDAMED
- Basic UDI-DI
- B-31111EY EUDAMED
- EMDN Code
- W010106020601 URINE TESTING CONTROLS 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
SG Calibrator Set by A. MENARINI Diagnostics 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-31111EY | Class IVD General | Active |
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Manufacturer
- Manufacturer
- A. MENARINI Diagnostics S.r.l.
- EUDAMED SRN
- IT-MF-000023427
Sources (1)
- EUDAMED 5462bc54-722e-4ce8-a0c2-e735f68b3cb5 61 fields · synced Jun 18, 2026