Data / Medical devices / Germany / Fresenius Medical Care Deutschland GMBH
Fresenius Medical Care Deutschland GMBH: FDA-registered device maker in SCHWEINFURT Bavaria, Germany, 1 510(k) clearance
Fresenius Medical Care Deutschland GMBH is registered with the FDA (registration 9611824) in SCHWEINFURT Bavaria, Germany. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 30, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9611824
- FEI number
- 3002806960
- Address
- Hafenstrasse 9, SCHWEINFURT Bavaria, Germany, D-97424
- Owner or operator
- FRESENIUS MEDICAL CARE (8010838)
- Roles
- Manufacturer
- First device listed
- June 10, 2025
- Registered through
- 2027
- Brand names listed
- 5008X Hemodialysis System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Blood Circuit, Hemodialysis | KOC | 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, 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 |
|---|---|---|---|---|---|---|
| May 30, 2025 | K243505 | 5008X Hemodialysis System | 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 Subsystem, Water Purification
- All makers of Accessories, Blood Circuit, Hemodialysis
- All makers of Disinfectant, Dialysate Delivery System
- All makers of Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Updated May 30, 2025. 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.