Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005578748

FEI Number

3005578748

Entity Name

Haemotec, a division of Fresenius Medical Care Canada Inc.

City/State/Country

VAUDREUIL-DORION Quebec, CA

Establishment Address

383 JOSEPH-CARRIER, VAUDREUIL-DORION Quebec J7V 5V5, CA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Fresenius Medical Care Renal Therapies Group, LLC (Owner Number: 9030510)

Owner / Operator Contact Address

920 WINTER STREET, --, Waltham, MA 02451, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K212620

PMA Number

N/A

All Registered Proprietary Names

NaturaLyte Liquid Acid Concentrate Citrasate Liquid Acid Concentrate

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KPO	Dialysate Concentrate For Hemodialysis (Liquid Or Powder)	Gastroenterology, Urology	Class 2	876.5820	2022-11-21

Official Correspondent

Rachel Lloyd

US Agent Details

DENISE OPPERMANN Business: FRESENIUS MEDICAL CARE NORTH AMERICA Email: Denise.M.Oppermann@freseniusmedicalcare.com Phone: (781) 9969103

Related Public Records

Same Entity

Fresenius Medical Care Renal Therapies Group, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3023981687	Erika of Texas	Pharr, TX, US
3012364195	Fresenius Medical Care de Mexico	Zapopan Jalisco, MX
3031565407	Erika de Reynosa, S.A. de C.V.	CD, Reynosa Tamaulipas, MX
3013546115	Fresenius USA Manufacturing, Inc.	Knoxville, TN, US
3005162618	Fresenius USA Manufacturing, Inc.	OREGON, OH, US

Similar Registrations

Registration Number	Establishment Name	Location
2431908	EDLAW PHARMACEUTICALS, INC.	E Farmingdale, NY, US
9616277	S.M.A.D.	L'ARBRESLE Rhone, FR
3027241826	RENAL CARE DIALYSIS SOLUTIONS, S.A. DE C.V.	El Marques Queretaro, MX
1225714	Fresenius Medical Care Renal Therapies Group, LLC	Waltham, MA, US
1528807	Nipro Renal Solutions USA, Corporation	LEWISBERRY, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005578748. Last updated year: 2026. Please use registration number 3005578748 when referencing this establishment in official correspondence.