Identity
- Trade Name
- Calprest ® NG-S EUDAMED
- Device Name
- Calprest® NG-S EUDAMED
- Model / Reference
- 9069S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08028169207216 EUDAMED
- Basic UDI-DI
- 802816920BW01020608023K EUDAMED
- EMDN Code
- W0102019009 CALPROTECTIN EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
No
EUDAMED
Calprest ® NG-S by Eurospital Spa — Class B — FDA_510K, IVDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K160447 | Class B | Active |
| FDA 510(k) | United States | FDA_510K | K130945 | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 802816920BW01020608023K | Class B | Active |
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Manufacturer
- Manufacturer
- Eurospital Spa
- EUDAMED SRN
- IT-MF-000028468
Sources (2)
- EUDAMED 4ecfa2e7-bc0f-4c62-b7b8-ed255043a764 61 fields · synced Jun 18, 2026
- FDA 510(k) K160447 1 fields · synced May 18, 2026