FDA Registration
Active
🇮🇹 Italy
SPES MEDICA S.P.A
Reg #: 3011534533
·
FEI: 3011534533
·
Expires 2026
Products
6
Proprietary Names
2
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- SPES MEDICA S.P.A
- Registration Number
- 3011534533
- FEI Number
- 3011534533
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Via Buccari 21
- City
- Genova Liguria
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K171102
Owner / Operator
- Firm Name
- Registrar Corp
- Operator Number
- 10088094
- Address
- Via Buccari 21
- City
- Genova
- State
- IT-NOTA
- Postal Code
- 16153
- Country
- IT
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2023-05-24 |
| Degreaser, Skin, Surgical | KOY | Class 1 | General, Plastic Surgery | No | 2023-05-24 |
| Media, Electroconductive | GYB | Class 2 | Neurology | No | 2023-05-24 |
| Cystometric Gas (Carbon-Dioxide) On Hydraulic Device | FAP | Class 2 | Gastroenterology, Urology | No | 2023-05-24 |
| Electrode, Cortical | GYC | Class 2 | Neurology | No | 2023-05-24 |
| Stimulator, Nerve | ETN | Class 2 | Ear, Nose, Throat | No | 2023-05-24 |
Proprietary Names
Gold Cup Electrode
Gold Cup Electrode, Silver Cup Electrode and Electrode with AG-AG/CL Coating and Conductive Plastic Electrode
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device