FDA Registration
Active
🇧🇪 Belgium
DIASAFEplusUS
Reg #: 3017491691
·
FEI: 3017491691
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- DSV Solutions NV
- Registration Number
- 3017491691
- FEI Number
- 3017491691
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Evenstuk 4
- City
- Gent Oost-Vlaanderen
- Country
- BE
Regulatory Submissions
- 510(k) Number
- K231534
Owner / Operator
- Firm Name
- FRESENIUS MEDICAL CARE
- Operator Number
- 8010838
- Address
- ELSE KROENER-STRASSE 1, --
- City
- BAD HOMBURG
- State
- Hesse
- Postal Code
- D-61352
- Country
- DE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Disinfectant, Dialysate Delivery System | NII | Class 2 | Gastroenterology, Urology | No | 2024-02-15 |
| Dialyzer, High Permeability With Or Without Sealed Dialysate System | KDI | Class 2 | Gastroenterology, Urology | No | 2024-02-15 |
| Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | FJK | Class 2 | Gastroenterology, Urology | No | 2024-02-15 |
| Subsystem, Water Purification | FIP | Class 2 | Gastroenterology, Urology | No | 2024-02-15 |
Proprietary Names
DIASAFEplusUS
Establishment Types
Export Device to the United States But Perform No Other Operation on Device