Data / Medical devices / Germany / Vivonic GMBH
Vivonic GMBH: FDA-registered device maker in Sailauf Bavaria, Germany, 6 510(k) clearances
Vivonic GMBH is registered with the FDA (registration 3010850471) in Sailauf Bavaria, Germany. It lists 1 device type. The FDA files 6 510(k) clearances under its listings, the newest dated November 14, 2025. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3010850471
- Address
- Kurfuerst-Eppstein-Ring 4, Sailauf Bavaria, Germany, 63877
- Owner or operator
- FRESENIUS MEDICAL CARE (8010838)
- Roles
- Manufacturer
- First device listed
- October 27, 2020
- Registered through
- 2027
- Brand names listed
- Aqua C UNO H, AquaA, AquaB LITE, AquaBplus, AquaBplus & AquaBplus B2, AquaBplus & AquaBplus B2 & AquaBplus HF, AquaBplus & AquaBplus HF, AquaC UNO H
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| November 14, 2025 | K250471 | AquaC UNO H | FIP | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| September 9, 2025 | K252181 | AquaA | FIP | Substantially Equivalent | Fresenius Medical Care North America | accessdata.fda.gov |
| June 13, 2024 | K232953 | AquaBplus; AquaB LITE | FIP | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| July 27, 2022 | K213507 | AquaA | FIP | Substantially Equivalent | Fresenius Medical Care Rental Therapies Group, LLC | accessdata.fda.gov |
| October 19, 2015 | K143617 | AquaC UNO H | FIP | Substantially Equivalent | Vivonic GmbH | accessdata.fda.gov |
| April 22, 2014 | K133829 | AQUABPLUS,AQUABPLUS & AQUABPLUS B2,AQUABPLUS&AQUABPLUS HF,AQUABPLUS& AQUABPLUS B2& AQUABLUS HF | FIP | Substantially Equivalent | Vivonic GmbH | accessdata.fda.gov |
Compare with other makers
Updated November 14, 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.