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FRESENIUS MEDICAL CARE AG & CO. KGAA

Brazil · Bad Homburg

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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 79 registration records and 112 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

45registered devices

Class I 5Class II 40

96 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

32active device licences

Class II 26Class III 6

88 including historic records

TWTaiwanTFDA

16valid device licences

Class I 1Class II 15

SGSingaporeHSA SMDR

6device registrations

CLASS B 2CLASS C 4

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

6active ARTG entries

Class I 2IIa 1IIb 3

HKHong KongMDACS

12valid listings

Class II 5Class III 7

ILIsraelAMAR

26registrations

RURussiaRoszdravnadzor

16active registrations

Class 2a 4Class 2b 11Class 3 1

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 States79 registration records, 112 510(k), 0 PMA, 17 excluded

Brazil45 confirmed, 11 excluded

Saudi Arabia0 confirmed, 2 excluded

Canada32 confirmed, 5 excluded

Manufacturer names merged into this page: FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH · Fresenius Medical Care Renal Therapies Group, LLC · Fresenius Medical Care de Mexico · Haemotec, a division of Fresenius Medical Care Canada Inc. · FRESENIUS MEDICAL CARE CANADA, INC. · FRESENIUS MEDICAL CARE AG

FDA 510(k) clearances by year

12006

32007

22008

22009

22010

42011

52012

52013

42014

42015

22016

42017

62018

22019

82020

62022

42023

52024

122025

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 1Dialysate Concentrate For Hemodialysis (Liquid Or Powder) 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
BR	80133959024	Reprocessadora de Filtro Dialisador Quality 1	Class II
BR	80133950158	Poltrona para hemodiálise Saubern	Class I
BR	80133950052	DIALESTERIL NEONATAL	Class II
CA	2	FRESENIUS CATHETER ADAPTER CONVERSION KIT	Class II
CA	7243	AUTOMATED INTEGRITY TESTER (AIT)	Class II
CA	13931	ON-LINE HDF FILTER	Class III