Vivonic G M B H

FDA Filings

This page includes the latest FDA filings for Vivonic G M B H. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

Registration Number	3010850471
FEI Number	3010850471
Name	Denise M Oppermann
Owner & Operator	Vivonic GmbH
Contact Address	Kurfuerst-Eppstein-Ring 4 Sailauf DE-BY Bayern 63877 DE
Official Correspondent	Andreas Hessberger 049-6093-9713111-x
US Agent	Denise M Oppermann Fresenius Medical Care North America 781 6994479 781 6999635 Denise.M.Oppermann@fmc-na.com
Registration Status	1
Initial Importer	N
Registration Expiration	2020-04-25
Registration Address	920 Winter Street Waltham, MA 02451 US
Establishment Type	Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 04251285200623 VIVONIC GmbH	AquaB LITE	2024-08-02
GUDID 04251285200616 VIVONIC GmbH	AquaB LITE	2024-08-02
GUDID 04251285200609 VIVONIC GmbH	AquaB LITE	2024-08-02
GUDID 04251285200593 VIVONIC GmbH	AquaB LITE	2024-08-02
GUDID 04251285200586 VIVONIC GmbH	AquaB LITE	2024-08-02
GUDID 04251285200579 VIVONIC GmbH	AquaB LITE	2024-08-02
GUDID 04251285200562 VIVONIC GmbH	AquaB LITE	2024-08-02
GUDID 04251285200555 VIVONIC GmbH	AquaB LITE	2024-08-02
GUDID 04251285200548 VIVONIC GmbH	AquaB LITE	2024-08-02
GUDID 04251285200531 VIVONIC GmbH	AquaB LITE	2024-08-02
GUDID 04251285200524 VIVONIC GmbH	AquaB LITE	2024-08-02
GUDID 04251285200517 VIVONIC GmbH	AquaDETECTOR	2022-08-16
GUDID 04251285200500 VIVONIC GmbH	Visual LED Indicator	2022-08-16
GUDID 04251285200494 VIVONIC GmbH	AquaA	2022-08-16
GUDID 04251285200487 VIVONIC GmbH	AquaA	2022-08-16
GUDID 04251285200470 VIVONIC GmbH	AquaA	2022-08-16
GUDID 04251285200463 VIVONIC GmbH	AquaA	2022-08-16
GUDID 04251285200456 VIVONIC GmbH	AquaA	2022-08-16
GUDID 04251285200449 VIVONIC GmbH	AquaA	2022-08-16
GUDID 04251285200432 VIVONIC GmbH	AquaA	2022-08-16
GUDID 04251285200425 VIVONIC GmbH	AquaA	2022-08-16
GUDID 04251285200418 VIVONIC GmbH	AquaA	2022-08-16
GUDID 04251285200401 VIVONIC GmbH	AquaA	2022-08-16
GUDID 04251285200395 VIVONIC GmbH	AquaA	2022-08-16
GUDID 04251285200388 VIVONIC GmbH	AquaA	2022-08-16
GUDID 04251285200371 VIVONIC GmbH	AquaA	2022-08-16
GUDID 04251285200364 VIVONIC GmbH	AquaA	2022-08-16
GUDID 04251285200357 VIVONIC GmbH	AquaA	2022-08-16
GUDID 04251285200340 VIVONIC GmbH	AquaA	2022-08-16
GUDID 04251285200333 VIVONIC GmbH	AquaA	2022-08-16
GUDID 04251285200326 VIVONIC GmbH	AquaA	2022-08-16
GUDID 04251285200319 VIVONIC GmbH	AquaA	2022-08-16
GUDID 04251285200296 VIVONIC GmbH	AquaBplus	2018-07-06
GUDID 04251285200289 VIVONIC GmbH	AquaBplus	2018-07-06
GUDID 04251285200272 VIVONIC GmbH	AquaBplus	2018-07-06
GUDID 04251285200265 VIVONIC GmbH	AquaBplus	2018-07-06
GUDID 04251285200258 VIVONIC GmbH	AquaBplus	2018-07-06
GUDID 04251285200241 VIVONIC GmbH	AquaBplus	2018-07-06
GUDID 04251285200234 VIVONIC GmbH	AquaC	2018-07-06
GUDID 04251285200227 VIVONIC GmbH	AquaBplus & AquaBplus B2 & AquaBplus HF	2018-07-06
GUDID 04251285200210 VIVONIC GmbH	AquaBplus & AquaBplus B2 & AquaBplus HF	2018-07-06
GUDID 04251285200203 VIVONIC GmbH	AquaBplus & AquaBplus B2 & AquaBplus HF	2018-07-06
GUDID 04251285200197 VIVONIC GmbH	AquaBplus & AquaBplus B2 & AquaBplus HF	2018-07-06
GUDID 04251285200180 VIVONIC GmbH	AquaBplus & AquaBplus B2 & AquaBplus HF	2018-07-06
GUDID 04251285200173 VIVONIC GmbH	AquaBplus & AquaBplus HF	2018-07-06
GUDID 04251285200166 VIVONIC GmbH	AquaBplus & AquaBplus HF	2018-07-06
GUDID 04251285200159 VIVONIC GmbH	AquaBplus & AquaBplus HF	2018-07-06
GUDID 04251285200142 VIVONIC GmbH	AquaBplus & AquaBplus HF	2018-07-06
GUDID 04251285200135 VIVONIC GmbH	AquaBplus & AquaBplus HF	2018-07-06
GUDID 04251285200128 VIVONIC GmbH	AquaBplus & AquaBplus HF	2018-07-06
GUDID 04251285200111 VIVONIC GmbH	AquaBplus & AquaBplus B2	2018-07-06
GUDID 04251285200104 VIVONIC GmbH	AquaBplus & AquaBplus B2	2018-07-06
GUDID 04251285200098 VIVONIC GmbH	AquaBplus & AquaBplus B2	2018-07-06
GUDID 04251285200081 VIVONIC GmbH	AquaBplus & AquaBplus B2	2018-07-06
GUDID 04251285200074 VIVONIC GmbH	AquaBplus & AquaBplus B2	2018-07-06
GUDID 04251285200067 VIVONIC GmbH	AquaBplus	2018-07-06
GUDID 04251285200050 VIVONIC GmbH	AquaBplus	2018-07-06
GUDID 04251285200043 VIVONIC GmbH	AquaBplus	2018-07-06
GUDID 04251285200036 VIVONIC GmbH	AquaBplus	2018-07-06
GUDID 04251285200029 VIVONIC GmbH	AquaBplus	2018-07-06
GUDID 04251285200012 VIVONIC GmbH	AquaBplus	2018-07-06
PMN K143617 \| FIP Denise M Oppermann [Vivonic GmbH]	AquaC UNO H	2015-11-05
PMN K143617 VIVONIC GMBH	AquaC UNO H	2015-10-19
PMN K133829 \| FIP Denise M Oppermann [Vivonic GmbH]	AquaBplus	2014-06-10
PMN K133829 \| FIP Denise M Oppermann [Vivonic GmbH]	AquaBplus & AquaBplus HF	2014-06-10
PMN K133829 \| FIP Denise M Oppermann [Vivonic GmbH]	AquaBplus & AquaBplus B2	2014-06-10
PMN K133829 \| FIP Denise M Oppermann [Vivonic GmbH]	AquaBplus & AquaBplus B2 & AquaBplus HF	2014-06-10
PMN K133829 VIVONIC GMBH	AQUABPLUS,AQUABPLUS & AQUABPLUS B2,AQUABPLUS&AQUABPLUS HF,AQUABPLUS& AQUABPLUS B2& AQUABLUS HF	2014-04-22

Related Finance Registrations

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092999192	Anvers,Belgium -> Norfolk, Virginia	WATER TREATMENT SUBSYSTEMS AND PARTS HS CODES 84212100	53 PCS
2020092999192	Anvers,Belgium -> Norfolk, Virginia	WATER TREATMENT SYSTEM SUBSYSTEMS AND PARTS HS CODE 84 21 21	53 PCS
2020091574025	Anvers,Belgium -> Norfolk, Virginia	WATER TREATMENT SUBSYSTEMS AND PARTS HS CODES 39172290,39173100, 39173200,39173900,39174000, 39191080,39235090,39259080, 39269097,40169300,68159900, 73072910,73072980,73089059,	64 PCS
2020091574025	Anvers,Belgium -> Norfolk, Virginia	WATER TREATMENT SYSTEM SUBSYSTEMS AND PARTS	64 PCS
2020091574025	Anvers,Belgium -> Norfolk, Virginia	WATER TREATMENT SYSTEM SUBSYSTEMS AND PARTS	64 PCS
2020082592511	Anvers,Belgium -> Norfolk, Virginia	WATER TREATMENT SYSTEMS AND PARTS HS CODES 84212100,84733020,84811099, 85371098	45 PCS
2020082592511	Anvers,Belgium -> Norfolk, Virginia	WATER TREATMENT SYSTEM	45 PCS
2020080770143	Anvers,Belgium -> Norfolk, Virginia	WATER TREATMENT SYSTEM SUBSYSTEMS AND PARTS	36 PCS
2020080770143	Anvers,Belgium -> Norfolk, Virginia	WATER TREATMENT SUBSYSTEMS AND PARTS HS CODES 84212100	36 PCS
2020072161860	Anvers,Belgium -> Norfolk, Virginia	WATER TREATMENT SUBSYSTEMS AND PARTS HS CODES 84212100,39173900, 39174000	59 PCS
2020072161860	Anvers,Belgium -> Norfolk, Virginia	WATER TREATMENT SYSTEM SUBSYSTEMS AND PARTS	59 PCS
2020052633072	Anvers,Belgium -> Norfolk, Virginia	WATER TREATMENT SYSTEM SUBSYSTEMS AND PARTS	51 PCS
2020052633072	Anvers,Belgium -> Norfolk, Virginia	WATER TREATMENT SUBSYSTEMS AND PARTS HS CODES 84212100	51 PCS
2020051944558	Anvers,Belgium -> Norfolk, Virginia	WATER TREATMENT SUBSYSTEMS AND PARTS HS CODES 84212100	54 PCS
2020051944558	Anvers,Belgium -> Norfolk, Virginia	WATER TREATMENT SYSTEM SUBSYSTEMS AND PARTS	54 PCS
2020050639724	Anvers,Belgium -> Norfolk, Virginia	WATER TREATMENT SYSTEM SUBSYSTEMS AND PARTS	53 PCS
2020050639724	Anvers,Belgium -> Norfolk, Virginia	WATER TREATMENT SUBSYSTEMS AND PARTS HS CODES 84212100 TEMPERATURE TO BE SET AT +20,0 C	53 PCS