FDA Registration
Active
🇮🇹 Italy
Galileo NT
Reg #: 3001687738
·
FEI: 3001687738
·
Expires 2025
Products
8
Proprietary Names
1
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- EB NEURO S.P.A.
- Registration Number
- 3001687738
- FEI Number
- 3001687738
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Via Bologna 1
- City
- Arbizzano di Valpolicella Verona
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K142064
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 |
|---|---|---|---|---|---|
| Stimulator, Photic, Evoked Response | GWE | Class 2 | Neurology | No | 2016-03-03 |
| Device, Nerve Conduction Velocity Measurement | JXE | Class 2 | Neurology | No | 2016-03-03 |
| Full-Montage Standard Electroencephalograph | GWQ | Class 2 | Neurology | No | 2016-03-03 |
| Non-Normalizing Quantitative Electroencephalograph Software | OLT | Class 2 | Neurology | No | 2016-03-03 |
| Stimulator, Electrical, Evoked Response | GWF | Class 2 | Neurology | No | 2016-03-03 |
| Standard Polysomnograph With Electroencephalograph | OLV | Class 2 | Neurology | No | 2016-03-03 |
| Electromyograph, Diagnostic | IKN | Class 2 | Physical Medicine | No | 2016-03-03 |
| Stimulator, Auditory, Evoked Response | GWJ | Class 2 | Neurology | No | 2016-03-03 |
Proprietary Names
Galileo NT
Establishment Types
Manufacture Medical Device