FDA Registration
Active
🇧🇪 Belgium
FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000
Reg #: 3017491691
·
FEI: 3017491691
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
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
- K220721
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 |
|---|---|---|---|---|---|
| Dialyzer, High Permeability With Or Without Sealed Dialysate System | KDI | Class 2 | Gastroenterology, Urology | No | 2023-07-28 |
Proprietary Names
FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000
Establishment Types
Export Device to the United States But Perform No Other Operation on Device