Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016096143

FEI Number

3016096143

Entity Name

TST GmbH

City/State/Country

Gernsheim Hesse, DE

Establishment Address

Marie-Curie-Str. 1a, Gernsheim Hesse 64579, DE

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on 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

K191407

PMA Number

N/A

All Registered Proprietary Names

FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000 AquaC UNO H pureFLOW 400, pureFLOW 401, pureFLOW 402, pureFLOW 406 AquaA Fresenius Sterile Stay Safe Cap 5008X Hemodialysis System bibag AquaBplus AquaB LITE AquaBplus & AquaBplus B2 & AquaBplus HF AquaBplus AquaBplus & AquaBplus B2 AquaBplus & AquaBplus HF Novalung

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2023-07-28
FIP	Subsystem, Water Purification	Gastroenterology, Urology	Class 2	876.5665	2020-10-27
KPO	Dialysate Concentrate For Hemodialysis (Liquid Or Powder)	Gastroenterology, Urology	Class 2	876.5820	2024-05-08
FIP	Subsystem, Water Purification	Gastroenterology, Urology	Class 2	876.5665	2022-08-03
KDJ	Set, Administration, For Peritoneal Dialysis, Disposable	Gastroenterology, Urology	Class 2	876.5630	2017-03-28
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
KPO	Dialysate Concentrate For Hemodialysis (Liquid Or Powder)	Gastroenterology, Urology	Class 2	876.5820	2018-06-28
FIP	Subsystem, Water Purification	Gastroenterology, Urology	Class 2	876.5665	2024-07-08
FIP	Subsystem, Water Purification	Gastroenterology, Urology	Class 2	876.5665	2015-04-09
FIP	Subsystem, Water Purification	Gastroenterology, Urology	Class 2	876.5665	2020-10-27
QJZ	Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure	Cardiovascular	Class 2	870.4100	2022-07-21

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
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
9611823	FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH	ST. WENDEL Saarland, 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
3015349756	DIALITY, INC.	Irvine, CA, US
9611824	FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH	SCHWEINFURT Bavaria, DE
3012149633	LIDER	MONTREVEL EN BRESSE Auvergne-Rhone-Alpes, FR
3005695808	SARMED SRL	IGLESIAS Sardegna, IT
3007137787	Nuwellis, Inc.	Eden Prairie, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016096143. Last updated year: 2026. Please use registration number 3016096143 when referencing this establishment in official correspondence.