FDA Registration
Active
🇮🇹 Italy
BIO-FLASH System Rinse
Reg #: 3007719797
·
FEI: 3007719797
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Instrumentation Laboratory SpA
- Registration Number
- 3007719797
- FEI Number
- 3007719797
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Zona Industriale Campolungo 327a, 11
- City
- Ascoli Piceno Marche
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K170314
Owner / Operator
- Firm Name
- Instrumentation Laboratory SpA
- Operator Number
- 10082968
- Address
- Viale Monza 338
- City
- Milan
- State
- Lombardy
- Postal Code
- 20128
- Country
- IT
- Correspondent
- Natale Bova
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Multipurpose For In Vitro Coagulation Studies | JPA | Class 2 | Hematology | No | 2024-11-25 |
Proprietary Names
BIO-FLASH System Rinse
HemosIL Acustar System Rinse
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)