Data / Medical devices / Canada / Haemotec, a division of Fresenius Medical Care Canada Inc.

Haemotec, a division of Fresenius Medical Care Canada Inc.: FDA-registered device maker in VAUDREUIL-DORION Quebec, Canada, 2 510(k) clearances

Name: Haemotec, a division of Fresenius Medical Care Canada Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Haemotec, a division of Fresenius Medical Care Canada Inc. is registered with the FDA (registration 3005578748) in VAUDREUIL-DORION Quebec, Canada. It lists 6 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 30, 2025. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3005578748
Address: 383 Joseph-Carrier, VAUDREUIL-DORION Quebec, Canada, J7V 5V5
Owner or operator: Fresenius Medical Care Renal Therapies Group, LLC (9030510)
Roles: Manufacturer
First device listed: November 21, 2022
Registered through: 2026
Brand names listed: 5008X CAREsystem, Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Blood Circuit, Hemodialysis	KOC	2	Manufacturer	accessdata.fda.gov
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)	KPO	2	Manufacturer	accessdata.fda.gov
Dialyzer, High Permeability With Or Without Sealed Dialysate System	KDI	2	Manufacturer	accessdata.fda.gov
Disinfectant, Dialysate Delivery System	NII	2	Manufacturer	accessdata.fda.gov
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	FJK	2	Manufacturer	accessdata.fda.gov
Subsystem, Water Purification	FIP	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 30, 2025	K243505	5008X Hemodialysis System	KDI	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC	accessdata.fda.gov
May 12, 2022	K212620	Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate	KPO	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC	accessdata.fda.gov

Compare with other makers

Updated May 30, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.