Identity
- Trade Name
- EasyCal EUDAMEDFDA UDI
- Generic Name
- Calprotectin IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- EasyCal EUDAMED
- Model / Reference
- 9062 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08028169204710 EUDAMEDFDA UDI
- Basic UDI-DI
- 802816920AW01020608022E EUDAMED
- Direct Marketing DI
- 08028169204710 EUDAMED
- FDA Product Code
- NXO FDA UDI
- EMDN Code
- W0102019009 CALPROTECTIN EUDAMED
- GMDN Term
- Calprotectin IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 866.5180 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
EasyCal by Eurospital Spa — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 802816920AW01020608022E | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Eurospital Spa
- EUDAMED SRN
- IT-MF-000028468
Sources (2)
- EUDAMED 7367e134-2551-4527-a117-999411309a32 61 fields · synced Jul 25, 2026
- FDA UDI bc1198bf-2b16-4f6e-92ff-795840a64072 33 fields · synced May 30, 2026