Fresenius Medical Care Holdings Inc

FDA Filings

This page includes the latest FDA filings for Fresenius Medical Care Holdings Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

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FSMEO

DUNS 958291411

Fresenius Medical Care Holdings Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• Fresenius Medical Care Seating (Australia) Pty. Ltd.
• Denise Oppermann

FDA Registration(s)

• Registration Number: 9616074
• FEI Number: 3002654698
• Name: Denise Oppermann
• Owner & Operator: Fresenius Medical Care Holdings, Inc.
• Contact Address: 920 Winter Street ; Waltham MA 02451 US
• Official Correspondent:
  • Denise Oppermann
  • 01-781-6994479-x
• US Agent:
  • Denise Oppermann
  • Fresenius Medical Care Holdings, Inc.
  • 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 ; North Waltham, MA 02451 US
• Establishment Type: Manufacture Medical Device

• Registration Number: 3003464075
• FEI Number: 3003464075
• Name: NXSTAGE MEDICAL, INC.
• Owner & Operator: Fresenius Medical Care Holdings, Inc.
• Contact Address: 920 Winter Street ; Waltham MA 02451 US
• Official Correspondent:
  • Denise Oppermann
  • 01-781-6994479-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 350 Merrimack St ; LAWRENCE, MA 01843 US
• Establishment Type:
  • Complaint File Establishment per 21 CFR 820.198
  • Develop Specifications But Do Not Manufacture At This Facility

• Registration Number: 2919260
• FEI Number: 3003464075
• Name: NxStage MDS Corporation
• Owner & Operator: Fresenius Medical Care Holdings, Inc.
• Contact Address: 920 Winter Street ; Waltham MA 02451 US
• Official Correspondent:
  • Denise Oppermann
  • 01-781-6994479-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 350 Merrimack St ; Lawrence, MA 01843 US

FDA Filings

Device Company	Device	Date
Venofer Fresenius Medical Care Holdings, Inc., American Regent, Inc., Vifor (International) Inc.	Prescription Medication	2024-11-21
GUDID 10840861102690 Fresenius Medical Care Holdings, Inc.	FX CorAL 1000 Dialyzer	2024-03-04
GUDID 10840861102683 Fresenius Medical Care Holdings, Inc.	FX CorAL 800 Dialyzer	2024-03-04
GUDID 10840861102676 Fresenius Medical Care Holdings, Inc.	FX CorAL 600 Dialyzer	2024-03-04
GUDID 10840861102669 Fresenius Medical Care Holdings, Inc.	FX CorAL 120 Dialyzer	2024-03-04
GUDID 10840861102652 Fresenius Medical Care Holdings, Inc.	FX CorAL 100 Dialyzer	2024-03-04
GUDID 10840861102638 Fresenius Medical Care Holdings, Inc.	FX CorAL 60 Dialyzer	2024-03-04
GUDID 10840861102409 Fresenius Medical Care Holdings, Inc.	CombiSet 03-2522-1	2023-10-27
GUDID 10840861102645 Fresenius Medical Care Holdings, Inc.	FX CorAL 80 Dialyzer	2023-10-12
GUDID 10840861102614 Fresenius Medical Care Holdings, Inc.	VersiPD	2023-02-22
GUDID 10840861102232 Fresenius Medical Care Holdings, Inc.	VersiPD	2023-02-22
GUDID 10840861102225 Fresenius Medical Care Holdings, Inc.	VersiPD	2023-02-22
GUDID 10840861102218 Fresenius Medical Care Holdings, Inc.	VersiPD	2023-02-22
Venofer Fresenius Medical Care Holdings, Inc., American Regent, Inc., Vifor (International) Inc.	Prescription Medication	2023-01-07
Venofer Fresenius Medical Care Holdings, Inc., American Regent, Inc., Vifor (International) Inc.	Prescription Medication	2022-07-26
Venofer Fresenius Medical Care Holdings, Inc., American Regent, Inc., Vifor (International) Inc.	Prescription Medication	2021-04-03
Venofer Fresenius Medical Care Holdings, Inc., American Regent, Inc., Vifor (International) Inc.	Prescription Medication	2020-12-16
Venofer Fresenius Medical Care Holdings, Inc., American Regent, Inc., Vifor (International) Inc.	Prescription Medication	2020-09-24
GUDID 10840861100771 Fresenius Medical Care Holdings, Inc.	stay.safe®	2020-03-30
GUDID 10840861101310 Fresenius Medical Care Holdings, Inc.	Bibag 08-4078-BB	2020-03-16
Venofer Fresenius Medical Care Holdings, Inc., American Regent, Inc., Vifor (International) Inc.	Prescription Medication	2020-02-27
KDI NXSTAGE MEDICAL, INC. [Fresenius Medical Care Holdings, Inc.]	NxStage Cartridge with Infusion Line	2019-10-29
KDI Denise Oppermann [Fresenius Medical Care Holdings, Inc.]	NX Stage Cartridge with Infusion Line	2019-10-23
GUDID 10840861102324 Fresenius Medical Care Holdings, Inc.	stay•safe® Handi-tool	2019-10-21
GUDID 10840861102317 Fresenius Medical Care Holdings, Inc.	stay•safe® organizer	2019-10-21
GUDID 10840861102300 Fresenius Medical Care Holdings, Inc.	stay•safe® organizer holder	2019-10-21
GUDID 10840861100177 Fresenius Medical Care Holdings, Inc.	Optiflux®	2019-10-21
GUDID 10840861100160 Fresenius Medical Care Holdings, Inc.	Optiflux®	2019-10-21
GUDID 10840861100153 Fresenius Medical Care Holdings, Inc.	Optiflux®	2019-10-21
GUDID 10840861100146 Fresenius Medical Care Holdings, Inc.	Optiflux®	2019-10-21
GUDID 10840861100023 Fresenius Medical Care Holdings, Inc.	Hemoflow™	2019-10-21
GUDID 10840861100016 Fresenius Medical Care Holdings, Inc.	Hemoflow™	2019-10-21
PMN K983076 | FIB NXSTAGE MEDICAL, INC. [Fresenius Medical Care Holdings, Inc.]	ViraGuard Viral Blocking Patient Transducer Protector	2019-09-25
PMN K983076 | FIB Denise Oppermann [Fresenius Medical Care Holdings, Inc.]	ViraGuard Viral Blocking Patient Transducer Protector	2019-09-25
PMN K133547 | KDI NXSTAGE MEDICAL, INC. [Fresenius Medical Care Holdings, Inc.]	NxStage Cartridge Express	2019-09-25
PMN K133547 | KDI Denise Oppermann [Fresenius Medical Care Holdings, Inc.]	NxStage Cartridge Express	2019-09-25
GUDID 00840861102037 Fresenius Medical Care Holdings, Inc.	Cycler Drain Bag Set 026-20226A	2019-06-19
GUDID 20840861100822 Fresenius Medical Care Holdings, Inc.	Fresenius HemaClip 04-9100-1	2019-06-07
GUDID 10840861100535 Fresenius Medical Care Holdings, Inc.	Fresenius 04-9300-7	2019-06-07
GUDID 10840861100528 Fresenius Medical Care Holdings, Inc.	Fresenius 04-9502-8	2019-06-07
GUDID 10840861100511 Fresenius Medical Care Holdings, Inc.	Fresenius 04-9006-5	2019-06-07
GUDID 10840861100498 Fresenius Medical Care Holdings, Inc.	MeDS Pump 04-7103-7	2019-06-07
GUDID 10840861100474 Fresenius Medical Care Holdings, Inc.	CombiSet 03-2795-7	2019-06-07
GUDID 10840861100337 Fresenius Medical Care Holdings, Inc.	CombiSet 03-2962-3	2019-06-07
GUDID 10840861100320 Fresenius Medical Care Holdings, Inc.	CombiSet 03-2922-7	2019-06-07
GUDID 10840861100313 Fresenius Medical Care Holdings, Inc.	CombiSet Twister 03-2794-0	2019-06-07
GUDID 10840861100306 Fresenius Medical Care Holdings, Inc.	CombiSet 03-2742-9	2019-06-07
GUDID 10840861100290 Fresenius Medical Care Holdings, Inc.	CombiSet 03-2722-9	2019-06-07
GUDID 10840861100283 Fresenius Medical Care Holdings, Inc.	CombiSet 03-2696-7	2019-06-07
GUDID 10840861100269 Fresenius Medical Care Holdings, Inc.	CombiSet 03-2692-6	2019-06-07
GUDID 10840861100252 Fresenius Medical Care Holdings, Inc.	CombiSet 03-2631-4	2019-06-07
GUDID 10840861100245 Fresenius Medical Care Holdings, Inc.	CombiSet 03-2630-6	2019-06-07
GUDID 10840861100238 Fresenius Medical Care Holdings, Inc.	CombiSet 03-2622-3	2019-06-07
GUDID 10840861100221 Fresenius Medical Care Holdings, Inc.	CombiSet 03-2621-5	2019-06-07
GUDID 00840861100415 Fresenius Medical Care Holdings, Inc.	CAREline 0342501	2019-06-07
Venofer Fresenius Medical Care Holdings, Inc., American Regent, Inc., Vifor (International) Inc.	Prescription Medication	2019-03-09
GUDID 10840861100214 Fresenius Medical Care Holdings, Inc.	Optiflux® Ultra	2018-12-03
GUDID 10840861100207 Fresenius Medical Care Holdings, Inc.	Optiflux® Ultra	2018-12-03
GUDID 10840861100191 Fresenius Medical Care Holdings, Inc.	Optiflux® Ultra	2018-12-03
GUDID 10840861100184 Fresenius Medical Care Holdings, Inc.	Optiflux® Ultra	2018-12-03
GUDID 10840861100108 Fresenius Medical Care Holdings, Inc.	Optiflux®	2018-10-22
GUDID 10840861100092 Fresenius Medical Care Holdings, Inc.	Optiflux®	2018-10-22
GUDID 10840861100757 Fresenius Medical Care Holdings, Inc.	Liberty® 050-87216	2018-10-01
GUDID 10840861100740 Fresenius Medical Care Holdings, Inc.	Liberty® 050-87215	2018-09-28
GUDID 10840861100733 Fresenius Medical Care Holdings, Inc.	Liberty® 050-87212	2018-09-28
GUDID 10840861100061 Fresenius Medical Care Holdings, Inc.	Hemoflow™	2018-09-24
GUDID 10840861100054 Fresenius Medical Care Holdings, Inc.	Hemoflow™	2018-09-24
GUDID 10840861100047 Fresenius Medical Care Holdings, Inc.	Hemoflow™	2018-09-24
GUDID 10840861100030 Fresenius Medical Care Holdings, Inc.	Hemoflow™	2018-09-24
GUDID 10840861100696 Fresenius Medical Care Holdings, Inc.	stay.safe®	2018-07-26
GUDID 10840861100580 Fresenius Medical Care Holdings, Inc.	stay.safe®	2018-07-26
GUDID 10840861100801 Fresenius Medical Care Holdings, Inc.	stay.safe®	2018-07-23
GUDID 10840861100788 Fresenius Medical Care Holdings, Inc.	stay.safe®	2018-07-23
GUDID 10840861100764 Fresenius Medical Care Holdings, Inc.	stay.safe®	2018-07-23
GUDID 10840861100795 Fresenius Medical Care Holdings, Inc.	stay.safe®	2018-07-19
GUDID 10840861101969 Fresenius Medical Care Holdings, Inc.	NaturaLyte 08-4400-1	2018-07-06
GUDID 10840861101112 Fresenius Medical Care Holdings, Inc.	Liberty® 026-20036A	2018-07-06
GUDID 10840861100818 Fresenius Medical Care Holdings, Inc.	Safe-Lock®	2018-07-06
GUDID 10840861100689 Fresenius Medical Care Holdings, Inc.	Premier	2018-07-06
GUDID 10840861100672 Fresenius Medical Care Holdings, Inc.	Premier	2018-07-06
GUDID 10840861100658 Fresenius Medical Care Holdings, Inc.	Safe-Lock®	2018-07-06
GUDID 10840861100627 Fresenius Medical Care Holdings, Inc.	Liberty® 026-20226	2018-07-06
GUDID 00840861101955 Fresenius Medical Care Holdings, Inc.	NaturaLyte 08-4112-2	2018-07-06
GUDID 00840861101948 Fresenius Medical Care Holdings, Inc.	NaturaLyte 08-4110-6	2018-07-06
GUDID 00840861100705 Fresenius Medical Care Holdings, Inc.	Safe-Lock®	2018-07-06
GUDID 20840861100631 Fresenius Medical Care Holdings, Inc.	DEL-CLAMP®	2018-03-29
GUDID 10840861101990 Fresenius Medical Care Holdings, Inc.	Liberty® PDx 050-87222	2018-03-29
GUDID 10840861101983 Fresenius Medical Care Holdings, Inc.	Liberty® PDx 050-87221	2018-03-29
GUDID 10840861101976 Fresenius Medical Care Holdings, Inc.	Liberty® PDx 050-87220	2018-03-29
GUDID 10840861101938 Fresenius Medical Care Holdings, Inc.	NaturaLyte 08-4000-LB	2018-03-29
GUDID 10840861101327 Fresenius Medical Care Holdings, Inc.	Bibag 08-4080-BB	2018-03-29
GUDID 10840861100665 Fresenius Medical Care Holdings, Inc.	Safe-Lock®	2018-03-29
GUDID 10840861100139 Fresenius Medical Care Holdings, Inc.	Optiflux®	2018-03-29
GUDID 10840861100122 Fresenius Medical Care Holdings, Inc.	Optiflux®	2018-03-29
GUDID 10840861100115 Fresenius Medical Care Holdings, Inc.	Optiflux®	2018-03-29
GUDID 10840861100085 Fresenius Medical Care Holdings, Inc.	Optiflux®	2018-03-29
GUDID 10840861100078 Fresenius Medical Care Holdings, Inc.	Optiflux®	2018-03-29
NDC 49230-530 Fresenius Medical Care Holdings, Inc.	Venofer	2011-01-27
NDC 49230-534 Fresenius Medical Care Holdings, Inc.	Venofer	2008-11-04

Similar & Related FDA Registered Companies

• American Regent, Inc.
• Vifor (International) Inc.

Related Finance Registrations

NCAGE Code	5DK23	FRESENIUS MEDICAL CARE HOLDINGS INC!DBA BMA LAS VEGAS DIV FRESENIUS!MEDICAL CARE-NORTH AMERICA
NCAGE Code	5DV56	FRESENIUS MEDICAL CARE HOLDINGS INC!DBA PLAINS REGIONAL DIALYSIS DIV!FRESENIUS MEDICAL CARE-NORTH AMERICA
NCAGE Code	6E2B8	FRESENIUS MEDICAL CARE HOLDINGS INC!DBA FRESENIUS MEDICAL CARE STEGER!DIV FRESENIUS MEDICAL CARE-NORTH!AMERICA
NCAGE Code	5UAC5	FRESENIUS MEDICAL CARE HOLDINGS INC!DBA FRESENIUS MEDICAL CARE HAYWARD!DIV FRESENIUS MEDICAL CARE-NORTH!AMERICA
NCAGE Code	6HXD9	FRESENIUS MEDICAL CARE HOLDINGS INC!DBA FRESENIUS MEDICAL CARE IRONTON!DIV FRESENIUS MEDICAL CARE-NORTH!AMERICA
NCAGE Code	5DVX2	FRESENIUS MEDICAL CARE HOLDINGS INC!DBA FMC DIALYSIS SERVICES OF!GLENDALE DIV FRESENIUS MEDICAL!CARE-NORTH AMERICA
NCAGE Code	5R9Q6	FRESENIUS MEDICAL CARE HOLDINGS INC!DBA FRESENIUS MEDICAL CARE KINGS!MILLS DIV FRESENIUS MEDICAL!CARE-NORTH AMERICA
NCAGE Code	63M72	FRESENIUS MEDICAL CARE HOLDINGS INC!DBA FRESENIUS MEDICAL CARE RIPON!SOUTH!DIV FRESENIUS MEDICAL CARE-NORTH!AMERICA
NCAGE Code	5RUQ5	FRESENIUS MEDICAL CARE HOLDINGS INC!DBA FRESENIUS MEDICAL CARE SOUTH!RAINBOW DIV FRESENIUS MEDICAL!CARE-NORTH AMERICA
NCAGE Code	6EDQ5	FRESENIUS MEDICAL CARE HOLDINGS INC!DBA FRESENIUS MEDICAL CARE MASONIC!HOMES!DIV FRESENIUS MEDICAL CARE-NORTH!AMERICA
CAGE Code	3MGP1	FRESENIUS MEDICAL CARE HOLDINGS, INC. FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS MEDICAL CARE-NORTH AMERICA
CAGE Code	5DK23	FRESENIUS MEDICAL CARE HOLDINGS INC BMA LAS VEGAS FRESENIUS MEDICAL CARE-NORTH AMERICA
CAGE Code	5DV56	FRESENIUS MEDICAL CARE HOLDINGS INC PLAINS REGIONAL DIALYSIS FRESENIUS MEDICAL CARE-NORTH AMERICA
CAGE Code	5DVX2	FRESENIUS MEDICAL CARE HOLDINGS INC FMC DIALYSIS SERVICES OF GLENDALE FRESENIUS MEDICAL CARE-NORTH AMERICA
CAGE Code	5R9Q6	FRESENIUS MEDICAL CARE HOLDINGS INC FRESENIUS MEDICAL CARE KINGS MILLS FRESENIUS MEDICAL CARE-NORTH AMERICA
CAGE Code	5RUQ5	FRESENIUS MEDICAL CARE HOLDINGS INC FRESENIUS MEDICAL CARE SOUTH RAINBOW FRESENIUS MEDICAL CARE-NORTH AMERICA
CAGE Code	5UAC5	FRESENIUS MEDICAL CARE HOLDINGS INC FRESENIUS MEDICAL CARE HAYWARD FRESENIUS MEDICAL CARE-NORTH AMERICA
CAGE Code	63M72	FRESENIUS MEDICAL CARE HOLDINGS INC FRESENIUS MEDICAL CARE RIPON SOUTH FRESENIUS MEDICAL CARE-NORTH AMERICA
CAGE Code	6E2B8	FRESENIUS MEDICAL CARE HOLDINGS INC FRESENIUS MEDICAL CARE STEGER FRESENIUS MEDICAL CARE-NORTH AMERICA
CAGE Code	6EDQ5	FRESENIUS MEDICAL CARE HOLDINGS INC FRESENIUS MEDICAL CARE MASONIC HOMES FRESENIUS MEDICAL CARE-NORTH AMERICA
CAGE Code	6HXD9	FRESENIUS MEDICAL CARE HOLDINGS INC FRESENIUS MEDICAL CARE IRONTON FRESENIUS MEDICAL CARE-NORTH AMERICA
S.A.M. Registration	3MGP1 [958291411]	FRESENIUS MEDICAL CARE HOLDINGS, INC. FRESENIUS MEDICAL CARE NORTH AMERICA
SEC	0001060398	FRESENIUS MEDICAL CARE HOLDINGS INC