FDA Registration
Active
🇩🇪 Germany
NEOSCAN SOLUTIONS GMBH
Reg #: 3033536331
·
FEI: 3033536331
·
Expires 2026
Products
1
Proprietary Names
1
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- NEOSCAN SOLUTIONS GMBH
- Registration Number
- 3033536331
- FEI Number
- 3033536331
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Joseph-von-Fraunhofer-Str. 6
- City
- Magdeburg Saxony-Anhalt
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K231133
Owner / Operator
- Firm Name
- Neoscan Solutions GmbH
- Operator Number
- 10091656
- Address
- Joseph-von-Fraunhofer-Str. 6
- City
- Magdeburg
- State
- Saxony-Anhalt
- Postal Code
- 39106
- Country
- DE
- Correspondent
- Daniel Gwinner
US Agent
- Business Name
- Neoscan Solutions Inc
- Contact Name
- Stefan Roell
- Address
- 150 N Michigan Ave Fl 35
- City
- Chicago
- State
- IL
- ZIP
- 60601
- Country
- US
- [email protected]
- Phone
- 312 5858013
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Nuclear Magnetic Resonance Imaging | LNH | Class 2 | Radiology | No | 2024-10-22 |
Proprietary Names
neo315
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device