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Sign in to claim this brandFresenius Medical Care
US
Last updated May 23, 2026
What Fresenius Medical Care makes
Fresenius Medical Care manufactures haemodialysis systems for institutional use, blood pressure cuffs that are reusable, and haemodialysis system dialysate pyrogen filters. Their specific products include the 5008X Hemodialysis System, Diasafe dialysate filters, and FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE in various series.
The company's devices are listed in the FDA 510(k) and FDA UDI registries and are classified as Class II medical devices. Fresenius Medical Care is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What does Fresenius Medical Care manufacture?
Fresenius Medical Care manufactures haemodialysis systems for institutional use, reusable blood pressure cuffs, and haemodialysis system dialysate pyrogen filters. Their specific products include the 5008X Hemodialysis System, Diasafe dialysate filters, and FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE in various series.
Where is Fresenius Medical Care based?
Fresenius Medical Care is based in the United States. The company operates from this location, which serves as its headquarters for manufacturing and distribution of medical devices.
Which regulatory registries list Fresenius Medical Care's devices?
Fresenius Medical Care's devices are listed in the FDA 510(k) and FDA UDI registries. These registries track medical devices that have been cleared for market in the United States, ensuring regulatory compliance and device identification.
How are Fresenius Medical Care's devices classified?
Fresenius Medical Care's devices are classified as Class II medical devices. This classification indicates they require special controls for safety and effectiveness, such as performance standards and labeling requirements, but are generally lower risk than Class III devices.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
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Catalogue (18)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Blood Pressure Cuff | F40016610 | FDA UDI | Class II | Active |
| 5008x | M204421 | FDA UDI | Class II | Active |
| Blood Pressure Cuff | F40016611 | FDA UDI | Class II | Active |
| 5008x | M204411 | FDA UDI | Class II | Active |
| Blood Pressure Cuff | F40016609 | FDA UDI | Class II | Active |
| Blood Pressure Cuff | F40016608 | FDA UDI | Class II | Active |
| Diasafe | 5008201 | FDA UDI | Class II | Active |
| Support plate | F50044946 | FDA UDI | Class II | Active |
| 5008x | M204431 | FDA UDI | Class II | Active |
| Hemoflow™ | 0500714S | FDA UDI | Class II | Unknown |
| Top Tray | F50044948 | FDA UDI | Class II | Active |
| 5008X Hemodialysis System | K231534 | FDA 510(k) | Class II | Active |
| Fresenius Naturalyte Granuflo Dry Acid Concentrate 10xx Series, 24xx Series, 30xx Series | K030497 | FDA 510(k) | Class II | Active |
| Fresenius 2008k | K994267 | FDA 510(k) | Class II | Active |
| Fresenius 2008t Hemodialysis Machine | K111639 | FDA 510(k) | Class II | Active |
| Fresenius Punctur-Guard Fistula Needle Sets | K023162 | FDA 510(k) | Class II | Active |
| Crit-Line Iv System | K141997 | FDA 510(k) | Class II | Active |
| \resenius Access Flow Reserving Connectors, Fresenius Standalone Accces Flow Reserving Connector | K022536 | FDA 510(k) | Class II | Active |
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