Data / Medical devices / Dialyzer, High Permeability With Or Without Sealed Dialysate System / Germany
FDA-registered makers of Dialyzer, High Permeability With Or Without Sealed Dialysate System in Germany: 7 establishments
7 establishments in Germany are registered with the FDA to make Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI). 5 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Product code
- KDI
- Country
- Germany
Makers of Dialyzer, High Permeability With Or Without Sealed Dialysate System in Germany
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Fresenius Medical Care Deutschland GMBH | ST. WENDEL Saarland, Germany | Manufacturer | 5 | February 10, 2026 | 0 | 0 | 0 | api.fda.gov |
| Gambro Dialysatoren GMBH | HECHINGEN Baden-Wurttemberg, Germany | Manufacturer | 4 | January 24, 2022 | 0 | 0 | 0 | api.fda.gov |
| B. Braun Avitum AG | MELSUNGEN Hesse, Germany | Complaint file establishment, Manufacturer, Specification developer | 2 | February 18, 2010 | 0 | 0 | 0 | api.fda.gov |
| B. Braun Avitum Saxonia GmbH | RADEBERG Saxony, Germany | Manufacturer | 2 | August 11, 2017 | 0 | 0 | 0 | api.fda.gov |
| Fresenius Medical Care Deutschland GMBH | SCHWEINFURT Bavaria, Germany | Manufacturer | 1 | May 30, 2025 | 0 | 0 | 0 | api.fda.gov |
| B.Braun Avitum Saxonia GmbH | Wilsdruff Saxony, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PAR MEDIZINTECHNIK GMBH & Co. KG | Berlin, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.