FDA Registration
Active
🇳🇱 Netherlands
BENELUX IMAGING
Reg #: 3029521953
·
FEI: 3029521953
·
Expires 2026
Products
6
Proprietary Names
0
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- BENELUX IMAGING
- Registration Number
- 3029521953
- FEI Number
- 3029521953
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Burgemeester Gulcherlaan 24
- City
- Hilversum Noord-Holland
- Country
- NL
Regulatory Submissions
- 510(k) Number
- K131576
- PMA Number
- P080003
Owner / Operator
- Firm Name
- Benelux Imaging
- Operator Number
- 10088672
- Address
- Burgemeester Gulcherlaan 24
- City
- Hilversum
- State
- Noord-Holland
- Postal Code
- 1217PC
- Country
- NL
- Correspondent
- Nick Vochteloo
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, X-Ray, Tomography, Computed | JAK | Class 2 | Radiology | No | 2024-12-17 |
| Digital Breast Tomosynthesis | OTE | Class 3 | Unknown | No | 2024-04-26 |
| Coil, Magnetic Resonance, Specialty | MOS | Class 2 | Radiology | No | 2025-02-12 |
| System, Nuclear Magnetic Resonance Imaging | LNH | Class 2 | Radiology | No | 2025-02-12 |
| System, Nuclear Magnetic Resonance Spectroscopic | LNI | Class 2 | Radiology | No | 2025-02-12 |
| System, Tomography, Computed, Emission | KPS | Class 2 | Radiology | No | 2026-03-31 |
Establishment Types
Export Device to the United States But Perform No Other Operation on Device