FDA Registration
Active
🇪🇸 Spain
NemoScan
Reg #: 3016446349
·
FEI: 3016446349
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SOFTWARE NEMOTEC, S.L.
- Registration Number
- 3016446349
- FEI Number
- 3016446349
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Av. Juan Caramuel, 1
- City
- Leganes Madrid (Province)
- Country
- ES
Regulatory Submissions
- 510(k) Number
- K232698
Owner / Operator
- Firm Name
- Software Nemotec, S.L.
- Operator Number
- 10062432
- Address
- Av. Juan Caramuel, 1
- City
- Leganés
- State
- Madrid (Province)
- Postal Code
- 28919
- Country
- ES
US Agent
- Business Name
- Regulatory Insight, Inc.
- Contact Name
- Kevin Walls
- Address
- 33 Golden Eagle Lane
- City
- Littleton
- State
- CO
- ZIP
- 80127
- Country
- US
- [email protected]
- Phone
- 720 9625412
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | Class 2 | Radiology | No | 2024-01-19 |
Proprietary Names
NemoScan
Establishment Types
Manufacture Medical Device