Home›USA›Fresenius Medical Care Renal Therapies Group, LLC

Fresenius Medical Care Renal Therapies Group, LLC

USA · Waltham

✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

13listed device types

Class I 0Class II 13Class III 0

plus 61 registration records and 55 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States61 registration records, 55 510(k), 0 PMA, 18 excluded

Canada0 confirmed, 5 excluded

Manufacturer names merged into this page: Fresenius Medical Care Renal Therapies Group, LLC

FDA 510(k) clearances by year

11980

11981

12013

32014

12015

22016

32017

62018

22019

72020

52022

42023

42024

112025

42026

FDA listed device types

showing 8 of 13

Autonomous Extracorporeal Blood Leak Detector/Alarm 1Subsystem, Water Purification 1Set, Tubing, Blood, With And Without Anti-Regurgitation Valve 1Disinfectant, Dialysate Delivery System 1System, Dialysate Delivery, Semi-Automatic, Peritoneal 1Hemodialysis System For Home Use 1Dialyzer, High Permeability With Or Without Sealed Dialysate System 1Accessories, Blood Circuit, Hemodialysis 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261267	Careflux H60;Careflux H70;Careflux V500	2026-07-24
US	K252377	NxStage System One with NxView	2026-05-15
US	K252459	multiFlux 130 (F00013123); multiFlux 160 (F00013124)	2026-02-10

Fresenius Medical Care Renal Therapies Group, LLC

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies