VIVONIC GMBH

FDA Device Registration & Listing · Sailauf Bavaria, DE · Registration 3010850471

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3010850471
FEI Number
3010850471
Entity Name
VIVONIC GMBH
City/State/Country
Sailauf Bavaria, DE
Establishment Address
Kurfuerst-Eppstein-Ring 4, Sailauf Bavaria 63877, DE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
FRESENIUS MEDICAL CARE (Owner Number: 8010838)
Owner / Operator Contact Address
ELSE KROENER-STRASSE 1, --, BAD HOMBURG, DE-HE D-61352, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K232953
PMA Number
N/A

All Registered Proprietary Names

AquaC UNO H AquaBplus & AquaBplus B2 & AquaBplus HF AquaBplus AquaBplus & AquaBplus B2 AquaBplus & AquaBplus HF AquaA Aqua C UNO H AquaA AquaBplus AquaB LITE

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2020-10-27
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2020-10-27
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2022-08-03
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2025-11-26
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2025-11-26
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2024-07-08

Official Correspondent

No official correspondent registered.

US Agent Details

Denise Oppermann Business: Vice President Regulatory Affairs NA Email: denise.m.oppermann@freseniusmedicalcare.com Phone: (781) 9969103

Related Public Records

Same Entity

FRESENIUS MEDICAL CARE
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
9611824 FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH SCHWEINFURT Bavaria, DE
9616277 S.M.A.D. L'ARBRESLE Rhone, FR
3043014136 GXO Logistics H France Andrezieux-Boutheon Loire, FR
3035708507 Pabst Transport GmbH & Co. KG Gochsheim Bavaria, DE
9611823 FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH ST. WENDEL Saarland, DE

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K110578 Mar Cor Purification, Inc. MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM 2011-05-20

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0004-05 Ameriwater Inc 2
AmeriWater Portable RO+, model numbers MR01 and MR02. The device is a reverse osmosis system for dialysis.

Similar Registrations

Registration Number Establishment Name Location
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2135346 CULLIGAN SOFT WATER SERVICE CO. Minnetonka, MN, US
3015349756 DIALITY, INC. Irvine, CA, US
3003550196 Veolia Water Treatment & Solutions ARLINGTON, TX, US
9611824 FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH SCHWEINFURT Bavaria, DE
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010850471. Last updated year: 2026. Please use registration number 3010850471 when referencing this establishment in official correspondence.
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