Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9611824

FEI Number

3002806960

Entity Name

FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH

City/State/Country

SCHWEINFURT Bavaria, DE

Establishment Address

HAFENSTRASSE 9, SCHWEINFURT Bavaria D-97424, 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

Expiration Date (Year)

2026

510(k) Number

K243505

PMA Number

N/A

All Registered Proprietary Names

5008X Hemodialysis System

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	2025-06-10
KOC	Accessories, Blood Circuit, Hemodialysis	Gastroenterology, Urology	Class 2	876.5820	2025-06-10
NII	Disinfectant, Dialysate Delivery System	Gastroenterology, Urology	Class 2	876.5860	2025-06-10
FJK	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	Gastroenterology, Urology	Class 2	876.5820	2025-06-10
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2025-06-10

Official Correspondent

No official correspondent registered.

US Agent Details

Denise Oppermann Business: VP 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
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
3016096143	TST GmbH	Gernsheim Hesse, 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
K811830	Cordis Corp.	C-DAK DUO-FLUX ARTIFICIAL KIDNEY	1981-09-21
K070320	Edwards Lifesciences Services GmbH	EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01	2007-06-07
K150880	Outset Medical	Tablo Console with Wireless Capability	2015-05-01

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.
Z-0019-2025	Outset Medical, Inc.	2	Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility.
Z-0028-2024	Fresenius Medical Care Holdings, Inc.	2	2008T Hemodialysis SYS, with CDX
Z-0029-2024	Fresenius Medical Care Holdings, Inc.	2	2008T Hemodialysis System without CDX
Z-0030-2024	Fresenius Medical Care Holdings, Inc.	2	2008T Hemodialysis System w/Bibag

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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
3010863450	AXIAL MEDICAL	Ivyland, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611824. Last updated year: 2026. Please use registration number 9611824 when referencing this establishment in official correspondence.