FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH

FDA Device Registration & Listing · ST. WENDEL Saarland, DE · Registration 9611823

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9611823
FEI Number
3002807005
Entity Name
FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH
City/State/Country
ST. WENDEL Saarland, DE
Establishment Address
FRANKFURTER STRASSE 6-8, ST. WENDEL Saarland D-66606, 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
N
Expiration Date (Year)
2026
510(k) Number
K243505
PMA Number
N/A

All Registered Proprietary Names

DIASAFEplusUS FX CorAL 40; FX CorAL 50 DIASAFEplusUS FX CorAL Dialyzers pureFLOW 400, pureFLOW 401, pureFLOW 402, pureFLOW 406 Bicarby Dialysate 5008X Hemodialysis System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NII Disinfectant, Dialysate Delivery System Gastroenterology, Urology Class 2 876.5860 2024-02-15
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2024-02-15
FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve Gastroenterology, Urology Class 2 876.5820 2024-02-15
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2024-02-15
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2015-04-09
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2026-01-22
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2026-01-15
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2025-11-26
KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder) Gastroenterology, Urology Class 2 876.5820 2024-05-08
KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder) Gastroenterology, Urology Class 2 876.5820 2025-11-26
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: Vice President 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
9611824 FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH SCHWEINFURT Bavaria, DE
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
3016096143 TST GmbH Gernsheim Hesse, DE

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
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
K110578 Mar Cor Purification, Inc. MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM 2011-05-20

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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
Z-0031-2024 Fresenius Medical Care Holdings, Inc. 2
2008T GEN 2 Bibag without CDX

Similar Registrations

Registration Number Establishment Name Location
9611824 FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH SCHWEINFURT Bavaria, DE
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611823. Last updated year: 2026. Please use registration number 9611823 when referencing this establishment in official correspondence.
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