Data / Medical devices / Germany / Fresenius Medical Care Deutschland GMBH
Fresenius Medical Care Deutschland GMBH: FDA-registered device maker in ST. WENDEL Saarland, Germany, 8 510(k) clearances
Fresenius Medical Care Deutschland GMBH is registered with the FDA (registration 9611823) in ST. WENDEL Saarland, Germany. It lists 7 device types. The FDA files 8 510(k) clearances under its listings, the newest dated February 10, 2026. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 9611823
- FEI number
- 3002807005
- Address
- Frankfurter Strasse 6-8, ST. WENDEL Saarland, Germany, D-66606
- Owner or operator
- FRESENIUS MEDICAL CARE (8010838)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- March 28, 2017
- Registered through
- 2027
- Brand names listed
- 5008X Hemodialysis System, Bicarby Dialysate, DIASAFEplusUS, FX CorAL 40; FX CorAL 50, FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000, FX CorAL Dialyzers, Fresenius Sterile Stay Safe Cap, multiFlux Dialyzers and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Blood Circuit, Hemodialysis | KOC | 2 | Manufacturer | accessdata.fda.gov |
| Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | KPO | 2 | Manufacturer | accessdata.fda.gov |
| Dialyzer, High Permeability With Or Without Sealed Dialysate System | KDI | 2 | Manufacturer | accessdata.fda.gov |
| Disinfectant, Dialysate Delivery System | NII | 2 | Manufacturer | accessdata.fda.gov |
| Set, Administration, For Peritoneal Dialysis, Disposable | KDJ | 2 | Contract manufacturer | accessdata.fda.gov |
| Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | FJK | 2 | Manufacturer | accessdata.fda.gov |
| Subsystem, Water Purification | FIP | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 10, 2026 | K252459 | multiFlux 130 (F00013123); multiFlux 160 (F00013124) | KDI | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| December 18, 2025 | K253518 | FX CorAL 40; FX CorAL 50 | KDI | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| October 9, 2025 | K251851 | DIASAFEplusUS (F00013010) | FIP | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| September 9, 2025 | K252180 | Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bicarby Dialysate RFP-453 (RFP-453-W); Bicarby Dialysate RFP-453 (RFP-453-G); Bicarby Dialysate RFP-454 (RFP-454-W); Bicarby Dialysate RFP-454 (RFP-454-G); Bicarby Dialysate RFP-456 (RFP-456-W) | KPO | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| May 30, 2025 | K243505 | 5008X Hemodialysis System | KDI | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| February 28, 2025 | K243874 | FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX CorAL 120 (F00012972); FX CorAL 600 (F00012973); FX CorAL 800 (F00012974); FX CorAL 1000 (F00012975) | KDI | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| December 1, 2023 | K233159 | pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504 | KPO | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| May 11, 2023 | K220721 | FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000 | KDI | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Dialyzer, High Permeability With Or Without Sealed Dialysate System
- All makers of Set, Administration, For Peritoneal Dialysis, Disposable
- All makers of Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
- All makers of Subsystem, Water Purification
- All makers of Accessories, Blood Circuit, Hemodialysis
- All makers of Disinfectant, Dialysate Delivery System
Updated February 10, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.