FDA Registration
Active
🇮🇹 Italy
Calprest®NG
Reg #: 9615139
·
FEI: 1000553563
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- EUROSPITAL S.P.A.
- Registration Number
- 9615139
- FEI Number
- 1000553563
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- VIA FLAVIA 122
- City
- TRIESTE
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K160447
Owner / Operator
- Firm Name
- EUROSPITAL S.P.A.
- Operator Number
- 9039568
- Address
- VIA FLAVIA 122, --
- City
- TRIESTE
- State
- IT-NOTA
- Postal Code
- 34147
- Country
- IT
- Correspondent
- Giulia Kropf
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Calprotectin, Fecal | NXO | Class 2 | Immunology | No | 2016-11-28 |
Proprietary Names
Calprest®NG
QUANTA Lite Calprotectin Extended Range
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device