FDA Registration
Active
🇮🇹 Italy
SPES MEDICA S.P.A
Reg #: 3005581220
·
FEI: 3005581220
·
Expires 2026
Products
5
Proprietary Names
3
Establishment Types
3
Classifications
5
Registration Details
- Registration Name
- SPES MEDICA S.P.A
- Registration Number
- 3005581220
- FEI Number
- 3005581220
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- VIA EUROPA-ZONA INDUSTRIALE
- City
- BATTIPAGLIA Salerno
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K061148
Owner / Operator
- Firm Name
- Spes Medica S.p.A.
- Operator Number
- 9082762
- Address
- Via Buccari 21
- City
- Genova
- State
- IT-GE
- 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 | 2006-02-06 |
| Cable, Electrode | IKD | Class 2 | Physical Medicine | No | 2021-12-08 |
| Stimulator, Nerve | ETN | Class 2 | Ear, Nose, Throat | No | 2014-12-02 |
| Electrode, Needle | GXZ | Class 2 | Neurology | No | 2019-12-02 |
| Electrode, Needle, Diagnostic Electromyograph | IKT | Class 2 | Physical Medicine | No | 2009-08-24 |
Proprietary Names
Disposable Adhesive Surface Electrodes
DryTouch Suction Stimulator
Spes Media Subdermal Needle Electrodes
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)