FDA Registration
Active
🇮🇹 Italy
Trea
Reg #: 9617286
·
FEI: 3003208775
·
Expires 2025
Products
5
Proprietary Names
2
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- EB NEURO, S.P.A.
- Registration Number
- 9617286
- FEI Number
- 3003208775
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- VIA PIETRO FANFANI 97/A
- City
- FLORENCE Tuscany
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K093728
Owner / Operator
- Firm Name
- EB NEURO, S.P.A.
- Operator Number
- 9043444
- Address
- VIA PIETRO FANFANI 97/A, --
- City
- FLORENCE
- State
- IT-NOTA
- Postal Code
- 50127
- Country
- IT
- Correspondent
- Christiano - Pineider
US Agent
- Business Name
- THEMA CORP
- Contact Name
- Silvia Tamarri
- Address
- 2929 Arch Street
- City
- Philadelphia
- State
- PA
- ZIP
- 19104
- Country
- US
- [email protected]
- Phone
- 215 8459459
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Full-Montage Standard Electroencephalograph | GWQ | Class 2 | Neurology | No | 2010-07-12 |
| Ventilatory Effort Recorder | MNR | Class 2 | Anesthesiology | No | 2010-07-12 |
| Standard Polysomnograph With Electroencephalograph | OLV | Class 2 | Neurology | No | 2010-07-12 |
| Amplifier, Physiological Signal | GWL | Class 2 | Neurology | No | 2010-07-12 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2010-07-12 |
Proprietary Names
Trea
BE MICRO
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)