Fresenius Kabi Deutschland G M B H

FDA Filings

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

Fresenius Kabi Deutschland G M B H holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

ROSE GMBH FUER MEDIZINTECHNIK

FDA Registration(s)

Registration Number	9681819
FEI Number	3000147578
Name	FRESENIUS KABI DEUTSCHLAND GMBH
Owner & Operator	Fresenius Kabi AG
Contact Address	- 61346 Bad Homburg DE-NOTA NONE DE
US Agent	Cheryl Roscher Fenwal, Inc, 847 5507909 847 5502960 cheryl.roscher@fresenius-kabi.com
Registration Status	1
Initial Importer	N
Registration Expiration	2020-04-25
Registration Address	5 ROBERT-KOCH-STRASSE BAD HERSFELD Hessen, D-36251 DE
Establishment Type	Develop Specifications But Do Not Manufacture At This Facility

Registration Number	3003708554
FEI Number	3003708554
Name	FRESENIUS KABI AUSTRIA GMBH
Owner & Operator	FRESENIUS KABI DEUTSCHLAND GMBH
Contact Address	ELSE-KRONER STRASSE 1 -- BAD HOMBURG V.D.H. DE-NOTA D-61325 DE
US Agent	Andrea Redd Senior Director, Regulatory Affairs 847 5505767 847 5507121 andrea.redd@fresenius-kabi.com
Registration Status	1
Initial Importer	N
Registration Expiration	2020-04-25
Registration Address	HAFNERSTRASSE 36 GRAZ Steiermark, A-8055 AT
Establishment Type	Sterilize Medical Device for Another Party (Contract Sterilizer)

FDA Filings

Device Company	Device	Date
Dextrose Fresenius Kabi USA, LLC, Fresenius Kabi Deutschland GmbH, HP Halden Pharma AS	Prescription Medication	2024-04-27
Sodium chloride Fresenius Kabi USA, LLC, Fresenius Kabi Norge AS, Fresenius Kabi Deutschland GmbH	Prescription Medication	2024-04-26
Sodium chloride Becton Dickinson and Company, Fresenius Kabi Deutschland GmbH, Fresenius Kabi Norge AS, Fresenius Medical Care North America, Fresenius Kabi USA, LLC	Prescription Medication	2024-01-13
Sodium chloride Fresenius Kabi USA, LLC, Fresenius Kabi Norge AS, Fresenius Kabi Deutschland GmbH	Prescription Medication	2023-07-22
Dextrose Fresenius Kabi USA, LLC, Fresenius Kabi Deutschland GmbH, HP Halden Pharma AS	Prescription Medication	2023-07-20
LACTATED RINGERS Becton Dickinson and Company, Fresenius Kabi Norge As, Fresenius Kabi Deutschland GmbH, Fresenius Medical Care North America	Prescription Medication	2023-04-29
Multiple Electrolytes pH 5.5 Fresenius Kabi USA, LLC, Fresenius Kabi Deutschland GmbH	Prescription Medication	2022-11-18
Multiple Electrolytes pH 7.4 Fresenius Kabi USA, LLC, Fresenius Kabi Deutschland GmbH	Prescription Medication	2022-11-18
Dextrose Fresenius Kabi USA, LLC, Fresenius Kabi Deutschland GmbH, HP Halden Pharma AS	Prescription Medication	2022-10-29
Sterile Water Fresenius Kabi USA, LLC, Fresenius Kabi Deutschland GmbH	Prescription Medication	2022-10-29
Sodium chloride Fresenius Kabi USA, LLC, Fresenius Kabi Deutschland GmbH, Fresenius Kabi Norge AS	Prescription Medication	2022-10-29
Sodium Chloride Fresenius Kabi USA, LLC, Fresenius Kabi Deutschland GmbH	Prescription Medication	2022-10-29
Dextrose Becton Dickinson and Company, Fresenius Kabi Norge AS, Fresenius Kabi Deutschland GmbH	Prescription Medication	2022-09-28
Sterile Water Becton Dickinson and Company, Fresenius Kabi Deutschland GmbH	Prescription Medication	2022-09-28
Intralipid Baxter Healthcare Corporation, Fresenius Kabi Deutschland GmbH, Fresenius Kabi AB Uppsala	Prescription Medication	2022-08-20
Intralipid Baxter Healthcare Corporation, Fresenius Kabi Deutschland GmbH, Fresenius Kabi AB Uppsala	Prescription Medication	2022-08-12
Intralipid Baxter Healthcare Corporation, Fresenius Kabi Deutschland GmbH, Fresenius Kabi AB Uppsala	Prescription Medication	2022-08-12
Intralipid Baxter Healthcare CORP, Fresenius Kabi Deutschland GmbH, Fresenius Kabi AB Uppsala	Prescription Medication	2022-07-30
Cardioplegic Solution Fresenius Kabi, USA, LLC, Fresenius Kabi Deutschland GmbH	Prescription Medication	2022-06-06
Dextrose Becton Dickinson and Company, Fresenius Kabi Deutschland GmbH	Prescription Medication	2022-05-11
Dextrose Fresenius Kabi USA, LLC, Fresenius Kabi Deutschland GmbH, Fresenius Kabi Norge AS	Prescription Medication	2022-03-02
Sodium chloride Fresenius Kabi USA, LLC, Fresenius Kabi Norge AS, Fresenius Kabi Deutschland GmbH	Prescription Medication	2022-03-01
Sodium chloride Fresenius Kabi USA, LLC, Fresenius Kabi Norge AS, Fresenius Kabi Deutschland GmbH	Prescription Medication	2022-03-01
Dextrose Fresenius Kabi USA, LLC, Fresenius Kabi Deutschland GmbH	Prescription Medication	2022-02-24
Sodium Chloride Fresenius Kabi USA, LLC, Fresenius Kabi Deutschland GmbH	Prescription Medication	2022-02-11
Sodium chloride Fresenius Kabi USA, LLC, Fresenius Kabi Norge AS, Fresenius Kabi Deutschland GmbH	Prescription Medication	2021-11-23
Sodium chloride Fresenius Kabi USA, LLC, Fresenius Kabi Norge AS, Fresenius Kabi Deutschland GmbH	Prescription Medication	2021-11-12
Dextrose Fresenius Kabi USA, LLC, Fresenius Kabi Deutschland GmbH, Fresenius Kabi Norge AS	Prescription Medication	2021-11-10
Dextrose Fresenius Kabi USA, LLC, Fresenius Kabi Deutschland GmbH, Fresenius Kabi Norge AS	Prescription Medication	2021-11-05
Sodium chloride Becton Dickinson and Company, Fresenius Kabi Deutschland GmbH, Fresenius Kabi Norge AS, Fresenius Medical Care North America, Fresenius Kabi USA, LLC	Prescription Medication	2021-10-28
Dextrose Becton Dickinson and Company, Fresenius Kabi Deutschland GmbH	Prescription Medication	2021-09-29
Sodium chloride Becton Dickinson and Company, Fresenius Kabi Deutschland GmbH, Fresenius Kabi Norge AS, Fresenius Medical Care North America, Fresenius Kabi USA, LLC	Prescription Medication	2021-05-08
Sodium chloride Fresenius Kabi USA, LLC, Fresenius Kabi Norge AS, Fresenius Kabi Deutschland GmbH	Prescription Medication	2021-04-15
DEXTROSE AND SODIUM CHLORIDE Fresenius Kabi USA, LLC, FRESENIUS KABI Deutschland GmbH	Prescription Medication	2021-03-01
3% Sodium Chloride Becton Dickinson and Company, Fresenius Kabi Deutschland GmbH	Prescription Medication	2021-02-04
Sodium chloride Becton Dickinson and Company, Fresenius Kabi Deutschland GmbH, Fresenius Kabi Norge AS, Fresenius Medical Care North America, Fresenius Kabi USA, LLC	Prescription Medication	2021-02-02
sodium chloride Becton Dickinson and Company, Fresenius Kabi Deutschland GmbH, Fresenius Kabi Norge AS	Prescription Medication	2021-02-02
LACTATED RINGERS Becton Dickinson and Company, Fresenius Kabi Norge As, Fresenius Kabi Deutschland GmbH, Fresenius Medical Care North America	Prescription Medication	2021-01-31
Dextrose and Sodium Chloride Fresenius Kabi USA, LLC, Fresenius Kabi Deutschland GmbH	Prescription Medication	2021-01-19
Dextrose and Sodium Chloride Fresenius Kabi USA, LLC, Fresenius Kabi Deutschland GmbH	Prescription Medication	2021-01-19
Dextrose and Sodium Chloride Fresenius Kabi USA, LLC, Fresenius Kabi Deutschland GmbH	Prescription Medication	2021-01-19
Dextrose and Sodium Chloride Fresenius Kabi USA, LLC, Fresenius Kabi Deutschland GmbH	Prescription Medication	2021-01-13
Sodium Chloride Fresenius Kabi USA, LLC, Fresenius Kabi Deutschland GmbH	Prescription Medication	2020-03-20
Dextrose Becton Dickinson and Company, Fresenius Kabi Norge AS, Fresenius Kabi Deutschland GmbH	Prescription Medication	2020-03-18
3% Sodium Chloride Becton Dickinson and Company, Fresenius Kabi Deutschland GmbH	Prescription Medication	2020-03-05
Sterile Water Becton Dickinson and Company, Fresenius Kabi Deutschland GmbH	Prescription Medication	2020-03-05
Dextrose Becton Dickinson and Company, Fresenius Kabi Deutschland GmbH	Prescription Medication	2020-02-14
Sodium chloride Fresenius Kabi USA, LLC, Fresenius Kabi Norge AS, Fresenius Kabi Deutschland GmbH	Prescription Medication	2020-01-24
Sodium Chloride Fresenius Kabi USA, LLC, Fresenius Kabi Deutschland GmbH	Prescription Medication	2020-01-22
Sodium chloride Becton Dickinson and Company, Fresenius Kabi Deutschland GmbH, Fresenius Kabi Norge AS, Fresenius Medical Care North America, Fresenius Kabi USA, LLC	Prescription Medication	2020-01-01
Voluven Hospira, Inc., Fresenius Kabi Deutschland GmbH, Fresenius Kabi AUT GmbH, Fresenius Kabi Norge AS	Prescription Medication	2019-12-14
PMN P160013 \| QBA FRESENIUS KABI AUSTRIA GMBH [FRESENIUS KABI DEUTSCHLAND GMBH]	OCS Lung Solution	2019-11-11
PMN P160013 \| PHO FRESENIUS KABI AUSTRIA GMBH [FRESENIUS KABI DEUTSCHLAND GMBH]	OCS Lung Solution	2019-11-11
Voluven Hospira, Inc., Fresenius Kabi Deutschland GmbH, Fresenius Kabi AUT GmbH, Fresenius Kabi Norge AS	Prescription Medication	2019-11-02
sodium chloride Becton Dickinson and Company, Fresenius Kabi Deutschland GmbH, Fresenius Kabi Norge AS	Prescription Medication	2019-07-19
Sodium Chloride Fresenius Kabi USA, LLC, Fresenius Kabi Deutschland GmbH	Prescription Medication	2019-07-16
Sterile Water Fresenius Kabi USA, LLC, Fresenius Kabi Deutschland GmbH	Prescription Medication	2019-07-04
Dextrose Fresenius Kabi USA, LLC, Fresenius Kabi Deutschland GmbH, HP Halden Pharma AS	Prescription Medication	2019-05-21
Sodium chloride Fresenius Kabi USA, LLC, Fresenius Kabi Deutschland GmbH, Fresenius Kabi Norge AS	Prescription Medication	2019-05-18
Sodium chloride Fresenius Kabi USA, LLC, Fresenius Kabi Deutschland GmbH, Fresenius Kabi Norge AS	Prescription Medication	2019-05-11
Dextrose Fresenius Kabi USA, LLC, Fresenius Kabi Deutschland GmbH	Prescription Medication	2019-04-26
Intralipid Baxter Healthcare CORP, Fresenius Kabi Deutschland GmbH, Fresenius Kabi AB Uppsala	Prescription Medication	2019-04-13
Intralipid Baxter Healthcare Corporation, Fresenius Kabi Deutschland GmbH, Fresenius Kabi AB Uppsala	Prescription Medication	2019-03-30
Intralipid Baxter Healthcare Corporation, Fresenius Kabi Deutschland GmbH, Fresenius Kabi AB Uppsala	Prescription Medication	2019-03-30
Intralipid Baxter Healthcare Corporation, Fresenius Kabi Deutschland GmbH, Fresenius Kabi AB Uppsala	Prescription Medication	2019-03-30
Intralipid Baxter Healthcare Corporation, Fresenius Kabi Deutschland GmbH, Fresenius Kabi AB Uppsala	Prescription Medication	2019-03-30
LACTATED RINGERS Becton Dickinson and Company, Fresenius Kabi Norge As, Fresenius Kabi Deutschland GmbH, Fresenius Medical Care North America	Prescription Medication	2019-03-28
Sodium Chloride Fresenius Kabi USA, LLC, Fresenius Kabi Deutschland GmbH	Prescription Medication	2018-12-22
Sodium chloride Becton Dickinson and Company, Fresenius Kabi Deutschland GmbH, Fresenius Kabi Norge AS, Fresenius Medical Care North America, Fresenius Kabi USA, LLC	Prescription Medication	2017-10-06
Sodium chloride Fresenius Kabi USA, LLC, Fresenius Kabi Norge AS, Fresenius Kabi Deutschland GmbH	Prescription Medication	2017-10-06
Dextrose Becton Dickinson and Company, Fresenius Kabi Norge AS, Fresenius Kabi Deutschland GmbH	Prescription Medication	2017-10-04
PMN P900056 \| MCX FRESENIUS KABI AUSTRIA GMBH [FRESENIUS KABI DEUTSCHLAND GMBH]	Rotaglide Lubricant	2014-05-19
PMN K121774 \| MCW FRESENIUS KABI AUSTRIA GMBH [FRESENIUS KABI DEUTSCHLAND GMBH]	Rotaglide Lubricant	2014-05-19
PMN K121613 \| FRN FRESENIUS KABI DEUTSCHLAND GMBH [Fresenius Kabi AG]	VOLUMAT MC AGILIA	2013-05-23
PMN K121613 \| FRN FRESENIUS KABI DEUTSCHLAND GMBH [Fresenius Kabi AG]	VOLUMAT LINES	2013-05-23
PMN K060316 FRESENIUS KABI DEUTSCHLAND GMBH	COMPAT GO ENTERAL FEEDING PUMP AND ADMINISTRATION SETS	2006-06-23

Similar & Related FDA Registered Companies

Related Finance Registrations

NCAGE Code	D2244	FRESENIUS KABI DEUTSCHLAND GMBH
CAGE Code	D2244	FRESENIUS KABI DEUTSCHLAND GMBH

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092829332	Bremerhaven,Federal Republic of Germany -> Savannah, Georgia	20 PACKAGES MEDICAL PRODUCTS VE-NO. 4000833785 WEIGHT 17.548,200KGS HS-CODE 30049000 . TEMPERATURE TO BE MAIN-	20 PKG
2020092829334	Bremerhaven,Federal Republic of Germany -> Savannah, Georgia	20 PACKAGES MEDICAL PRODUCTS VE-NO. 4000833786 WEIGHT 17.548,200KGS HS-CODE 30049000 . TEMPERATURE TO BE MAIN-	20 PKG
2020092848140	Bremerhaven,Federal Republic of Germany -> Savannah, Georgia	20 PACKAGES MEDICAL PRODUCTS VE-NO. 4000834152 WEIGHT 17549,900 KGS HS-CODE 30049000 . TEMPERATURE TO BE MAIN-	20 PKG
2020092847791	Bremerhaven,Federal Republic of Germany -> Savannah, Georgia	20 PACKAGES MEDICAL PRODUCTS VE-NO. 4000834151 WEIGHT 17.505,800KGS HS-CODE 30049000 . TEMPERATURE TO BE MAIN-	20 PKG
2020092829335	Bremerhaven,Federal Republic of Germany -> Savannah, Georgia	20 PACKAGES MEDICAL PRODUCTS VE-NO. 4000833787 WEIGHT 17.548,200KGS HS-CODE 30049000 . TEMPERATURE TO BE MAIN-	20 PKG
2020092550652	Bremerhaven,Federal Republic of Germany -> Norfolk, Virginia	INSPECTION MACHINE HS CODE 9031.80.80	5 PCS
2020092550652	Bremerhaven,Federal Republic of Germany -> Norfolk, Virginia	INSPECTION MACHINE HS CODE 9031.80.80 CTC CLARI SCHUYLER PHONE OFFICE 1 716 685-958	5 PCS
2020092252120	Bremerhaven,Federal Republic of Germany -> Savannah, Georgia	20 PACKAGES MEDICAL PRODUCTS VE-NO. 4000833788 WEIGHT 17.548,200GS HS-CODE 30049000 . TEMPERATURE TO BE	20 PKG
2020092241886	Bremerhaven,Federal Republic of Germany -> Savannah, Georgia	20 PACKAGES MEDICAL PRODUCTS VE-NO. 4000833778 WEIGHT 17.548,200KGS HS-CODE 30049000 . TEMPERATURE TO BE MAIN-	20 PKG