Data / Medical devices / Germany / Fresenius Hemocare GMBH
Fresenius Hemocare GMBH: FDA-registered device maker in Friedberg Hesse, Germany, 6 510(k) clearances
Fresenius Hemocare GMBH is registered with the FDA (registration 3004634229) in Friedberg Hesse, Germany. It lists 6 device types. The FDA files 6 510(k) clearances under its listings, the newest dated February 11, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004634229
- Address
- Gruener Weg 10, Friedberg Hesse, Germany, D-61169
- Owner or operator
- Fresenius Kabi AG (9027285)
- Roles
- Exporter to the US, Manufacturer, Specification developer
- First device listed
- October 19, 2007
- Registered through
- 2026
- Brand names listed
- AT1 Autotransfusion Set, ATF 120 Fast Start Kit, ATF 40 Fast Start Kit, CATSmart, CATSmart System, CATSmart, Automated Blood Processing Autotransfusion System, COM.TEC CELL SEPARATOR, COMPODOCK and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apparatus, Autotransfusion | CAC | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Device, Blood Mixing And Blood Weighing | KSQ | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Hematocrit, Tube, Rack, Sealer, Holder | GHY | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Separator, Automated, Blood Cell And Plasma, Therapeutic | LKN | U | Exporter to the US, Specification developer | accessdata.fda.gov |
| Set, Transfer (Blood/Plasma) | KSB | 2 | Specification developer | accessdata.fda.gov |
| Supplies, Blood-Bank | KSS | 1 | 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 11, 2021 | K210089 | CATSmart, Automated Blood Processing Autotransfusion System | CAC | Substantially Equivalent | Fresenius Kabi AG | accessdata.fda.gov |
| September 27, 2019 | K192368 | CATSmart | CAC | Substantially Equivalent | Fresenius Kabi AG | accessdata.fda.gov |
| December 10, 2018 | K180831 | CATSmart | CAC | Substantially Equivalent | Fresenius Kabi AG | accessdata.fda.gov |
| September 16, 2016 | K160735 | CATSmart | CAC | Substantially Equivalent | Fresenius Kabi AG | accessdata.fda.gov |
| September 5, 2006 | K060734 | FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR, MODEL 9008031; FRESENIUS C5L, S5L, C5L-T PLATELET SETS (5-DAY STORAGE) | LKN | Substantially Equivalent | Fresenius Medical Care North America | accessdata.fda.gov |
| July 31, 1996 | K960006 | C.A.T.S. CONTINUOUS AUTOTRANSFUSION SYSTEM | CAC | Substantially Equivalent | Fresenius AG | accessdata.fda.gov |
Compare with other makers
- All makers of Apparatus, Autotransfusion
- All makers of Set, Transfer (Blood/Plasma)
- All makers of Separator, Automated, Blood Cell And Plasma, Therapeutic
- All makers of Supplies, Blood-Bank
- All makers of Hematocrit, Tube, Rack, Sealer, Holder
- All makers of Device, Blood Mixing And Blood Weighing
Updated February 11, 2021. 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.