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FRESENIUS MEDICAL CARE CANADA, INC.

Canada · Richmond Hill

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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

6listed device types

Class I 0Class II 6Class III 0

plus 2 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

43registered devices

Class I 5Class II 38

94 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

16active device licences

Class II 11Class III 5

52 including historic records

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 States2 registration records, 7 510(k), 0 PMA, 28 excluded

Brazil43 confirmed, 12 excluded

Saudi Arabia0 confirmed, 2 excluded

Canada16 confirmed, 6 excluded

Manufacturer names merged into this page: Haemotec, a division of Fresenius Medical Care Canada Inc. · FRESENIUS MEDICAL CARE CANADA, INC. · FRESENIUS MEDICAL CARE AG · FRESENIUS MEDICAL CARE LTDA · FRESENIUS MEDICAL CARE AG&CO.KGAA · FRESENIUS MEDICAL CARE AG & CO. KGAA

Business registration

Corporation number: 11798448
Registration status: Active
Legal form: Canada Business Corporations Act
Incorporated: 2020-01-01
Registered address: 45 Staples Avenue, Richmond Hill, ON, L4B 4W6

Business registration data from Corporations Canada, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12000 · K994267

12002 · K022536

22003 · K030497

12011 · K111639

12015 · K141997

12024 · K231534

FDA listed device types

Subsystem, Water Purification 1Set, Tubing, Blood, With And Without Anti-Regurgitation Valve 1Disinfectant, Dialysate Delivery System 1Dialyzer, High Permeability With Or Without Sealed Dialysate System 1Dialysate Concentrate For Hemodialysis (Liquid Or Powder) 1Accessories, Blood Circuit, Hemodialysis 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K231534	5008X Hemodialysis System	2024-02-02
US	K141997	CRIT-LINE IV SYSTEM	2015-04-01
US	K111639	FRESENIUS 2008T HEMODIALYSIS MACHINE	2011-10-21
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

FRESENIUS MEDICAL CARE CANADA, INC.

Registrations by market

How these numbers were verified

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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