FDA Registration
Active
🇪🇸 Spain
SENTINELLA 102
Reg #: 3008962177
·
FEI: 3008962177
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- GENERAL EQUIPMENT FOR MEDICAL IMAGING, S.A.
- Registration Number
- 3008962177
- FEI Number
- 3008962177
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- C/Jeronimo de Monsoriu 92 Bajo Izda
- City
- Valencia
- Country
- ES
Regulatory Submissions
- 510(k) Number
- K143156
Owner / Operator
- Firm Name
- GENERAL EQUIPMENT FOR MEDICAL IMAGING, S.A.
- Operator Number
- 10035514
- Address
- Jeronimo de Monsoriu n 92 Bajo Izq
- City
- Valencia
- State
- ES-V
- Postal Code
- 46022
- Country
- ES
- Correspondent
- Ivan Navarro
US Agent
- Business Name
- Spain US Chamber of Commerce
- Contact Name
- Nicolas Fontanillas
- Address
- 2153 coral way suite 400 Miami
- City
- Miami
- State
- FL
- ZIP
- 33145
- Country
- US
- [email protected]
- Phone
- 305 3585988
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Camera, Scintillation (Gamma) | IYX | Class 1 | Radiology | No | 2014-12-30 |
Proprietary Names
SENTINELLA 102
SENTINELLA 102 HORUS
Establishment Types
Manufacture Medical Device