Home›France›BAXTER HEALTHCARE CORPORATION (BAXTER S.A. MANUFACTURING)

BAXTER HEALTHCARE CORPORATION (BAXTER S.A. MANUFACTURING)

France · La Chatre

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada — 4 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

64listed device types

Class I 17Class II 41Class III 5unclassified 1

plus 195 registration records and 569 510(k), 165 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

49registered devices

Class I 9Class II 40

57 including historic records

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

83active device licences

Class II 60Class III 20Class IV 3

184 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 States195 registration records, 569 510(k), 165 PMA, 36 excluded

Brazil49 confirmed, 8 excluded

Saudi Arabia1 confirmed, 0 excluded

Canada83 confirmed, 8 excluded

Manufacturer names merged into this page: BAXTER HEALTHCARE CORPORATION · Baxter Healthcare, S.A. · Baxter Healthcare Corporation · BAXTER HEALTHCARE CORPORATION (BAXTER S.A. MANUFACTURING) · BAXTER HEALTHCARE SA · BAXTER HEALTHCARE S.A.

FDA 510(k) clearances by year

62006

42007

42008

42009

12010

62011

22012

42013

42014

42015

22016

42017

42018

42019

72020

52021

92022

42023

52024

52025

FDA listed device types

showing 8 of 64

Sealant, Polymerizing 1Absorbable Collagen Hemostatic Agent With Thrombin 1Agent, Absorbable Hemostatic, Collagen Based 1Barrier, Absorbable, Adhesion 1Agent, Absorbable Hemostatic, Non-Collagen Based 1Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) 1Dialyzer, High Permeability With Or Without Sealed Dialysate System 1System, Irrigation, Urological 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K251745	Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)	2025-12-16
US	K251636	Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)	2025-07-28
US	K251640	SIGMA Spectrum Infusion Pump with Master Drug Library	2025-07-28
BR	10068390316	EQUIPO PARA PACLITAXEL COM ENTRADA DE AR	Class II
BR	80145240404	BOLSA DE EVA VAZIA EXACTAMIX	Class II
BR	80145249068	INFUSOR LV com Sistema de infusão Portátil em Elastómero	Class II
SA	ME0000003501SFDAA00001	Clamp for outlet port of PD bag	—
CA	8741	MCA HEMODIALYZER	Class III
CA	8795	HEMOSTATIC SEALANT	Class IV
CA	32	CRYOCYTE MANIFOLD SET	Class II

BAXTER HEALTHCARE CORPORATION (BAXTER S.A. MANUFACTURING)

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