Fresenius Medical Care

FDA Filings

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

FDA Registration(s)

• Registration Number: 9611823
• FEI Number: 3002807005
• Name: Denise Oppermann
• Owner & Operator: FRESENIUS MEDICAL CARE
• Contact Address: ELSE KROENER-STRASSE 1 --; BAD HOMBURG DE-HE Hessen D-61352 DE
• US Agent:
  • Denise Oppermann
  • Senior Director of Regulatory Affairs, Devices
  • 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
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

• Registration Number: 9616277
• FEI Number: 3003244997
• Name: DENISE OPPERMANN
• Owner & Operator: FRESENIUS MEDICAL CARE
• Contact Address: ELSE KROENER-STRASSE 1 --; BAD HOMBURG DE-HE Hessen D-61352 DE
• US Agent:
  • DENISE OPPERMANN
  • FRESENIUS MEDICAL CARE NORTH AMERICA
  • 781 6994479 0
  • 781 6999635
  • denise.m.oppermann@fmc-na.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 920 Winter St ; North Waltham, MA 02451 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

• Registration Number: 3016096143
• FEI Number: 3016096143
• Name: Trans Service Team GmbH
• Owner & Operator: FRESENIUS MEDICAL CARE
• Contact Address: ELSE KROENER-STRASSE 1 --; BAD HOMBURG DE-HE Hessen D-61352 DE
• US Agent:
  • Denise Oppermann
  • 781 6994479 0
  • 781 6999635
  • denise.m.oppermann@fmc-na.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Marie-Curie-Str. 1a ; Gernsheim Hessen, 64579 DE
• Establishment Type: Export Device to the United States But Perform No Other Operation on Device

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
PMN K162716 | KPO Trans Service Team GmbH [FRESENIUS MEDICAL CARE]	bibag	2018-06-28
PMN K162716 | KPO DENISE OPPERMANN [FRESENIUS MEDICAL CARE]	bibag	2018-06-28
PMN K083542 | KDJ Denise Oppermann [FRESENIUS MEDICAL CARE]	Fresenius Sterile Stay Safe Cap	2017-03-28
PMN K141997 FRESENIUS MEDICAL CARE	CRIT-LINE IV SYSTEM	2015-04-01
PMN K111639 FRESENIUS MEDICAL CARE	FRESENIUS 2008T HEMODIALYSIS MACHINE	2011-10-21
PMN K030497 FRESENIUS MEDICAL CARE	FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES, 30XX SERIES	2003-05-20
PMN K023162 FRESENIUS MEDICAL CARE	FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS	2003-03-20
PMN K022536 FRESENIUS MEDICAL CARE	\RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RESERVING CONNECTOR	2002-10-30
PMN K994267 FRESENIUS MEDICAL CARE	FRESENIUS 2008K	2000-03-16

Similar & Related FDA Registered Companies

• Fresenius Medical Care North America
• Fresenius Medical Care Holdings, Inc.
• Fresenius Medical Care Seating Australia Pty Ltd.
• Fresenius Medical Care Renal Therapies Group, LLC
• Fresenius Medical Care Rental Therapies Group, LLC
• Fresenius Medical Care Reanal Therapies Group LLC
• FRESENIUS MEDICAL CARE, NORTH AMERICA - RENAL THER
• FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE
• FRESENIUS MEDICAL CARE SOUTH ASIA PACIFIC PTY LTD.
• Fresenius Medical Care de Mexico, S.A. de C.V.
• Fresenius Medical Care AG & Co. KGaA

Related Finance Registrations

NCAGE Code	643X0	FRESENIUS MEDICAL CARE!DBA FRESENIUS MEDICAL CARE SHALER!DIV FRESENIUS MEDICAL CARE-NORTH!AMERICA
CAGE Code	643X0	FRESENIUS MEDICAL CARE FRESENIUS MEDICAL CARE SHALER FRESENIUS MEDICAL CARE-NORTH AMERICA

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092975636	Anvers,Belgium -> Charleston, South Carolina	565 PARCELS LOADED ON 20 PALETTS PHARMACEUTICALS HS CODE 3004.90 . TRANSPORT TEMPERATURE PLUS 20CELSIUS	565 PKG
2020092952377	Anvers,Belgium -> Charleston, South Carolina	669 PARCELS LOADED ON 23 PALETTS PHARMACEUTICALS HS CODE 3004.90 . TRANSPORT TEMPERATURE PLUS 20CELSIUS	669 PKG
2020092965281	57073 -> Long Beach, California	ISOLATION GOWN NON SURGICAL	623 PKG
2020092976908	57073 -> Long Beach, California	ISOLATION GOWN NON SURGICAL	649 PKG
2020092816144	Stadersand,Federal Republic of Germany -> Oakland, California	MEDICAL EQUIPMENT	15 PKG
2020092815655	Yantian,China (Mainland) -> Long Beach, California	DISPOSABLE MEDICAL PRODUCT	1810 CTN
2020092663206	Anvers,Belgium -> Houston, Texas	= UPON 25 PALLETS REF.: 6002 4703 STAY.SAFE C AP- HS-CODE: 39174000	1200 PKG
2020092663206	Anvers,Belgium -> Houston, Texas	= UPON 25 PALLETS REF.: 6002 1130 STAY.SAFE C AP- UNSTERILE HS-CODE: 39174000	1200 PKG
2020092663206	Anvers,Belgium -> Houston, Texas	= UPON 25 PALLETS REF.: 6002 1131 STAY.SAFE C AP- UNSTERILE HS-CODE: 39174000	1200 PKG
2020092637194	Anvers,Belgium -> Houston, Texas	SODIUM BICARBONATE TEMPSET: +20 CELSIUSVENTS: CLOSED	115 PKG
2020092637194	Anvers,Belgium -> Houston, Texas	SODIUM BICARBONATE TEMPSET: +20 CELSIUSVENTS: CLOSED	115 PKG
2020092637194	Anvers,Belgium -> Houston, Texas	SODIUM BICARBONATE TEMPSET: +20 CELSIUSVENTS: CLOSED	115 PKG
2020092637194	Anvers,Belgium -> Houston, Texas	SODIUM BICARBONATE TEMPSET: +20 CELSIUSVENTS: CLOSED	115 PKG
2020092637194	Anvers,Belgium -> Houston, Texas	SODIUM BICARBONATE TEMPSET: +20 CELSIUSVENTS: CLOSED	115 PKG