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Baxter Healthcare, S.A.

Dominican Republic · Haina San Cristobal

✓ Record-verifiedregistrations found in 11 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 11 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

96listed device types

Class I 32Class II 58Class III 5unclassified 1

plus 244 registration records and 657 510(k), 165 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

51registered devices

Class I 11Class II 40

59 including historic records

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

94active device licences

Class II 66Class III 25Class IV 3

197 including historic records

TWTaiwanTFDA

5valid device licences

Class II 5

SGSingaporeHSA SMDR

33device registrations

CLASS B 21CLASS C 9CLASS D 3

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

75active ARTG entries

Class I 7Class III 12IIa 23IIb 18Class Im (measuring) 1Class Is (sterile) 14

HKHong KongMDACS

18valid listings

Class II 5Class III 8Class IV 5

ILIsraelAMAR

46registrations

RURussiaRoszdravnadzor

23active registrations

Class 2a 7Class 2b 9Class 3 7

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 States244 registration records, 657 510(k), 165 PMA, 23 excluded

Brazil51 confirmed, 6 excluded

Saudi Arabia1 confirmed, 0 excluded

Canada94 confirmed, 6 excluded

Manufacturer names merged into this page: BAXTER HEALTHCARE CORPORATION · Baxter Healthcare, S.A. · Baxter Healthcare of Puerto Rico LLC · Baxter Healthcare - Tel Aviv · BAXTER HEALTHCARE CORPORATION A DIVISION OF BAXTER INTERNATIONAL, INC. · BAXTER HEALTHCARE CORPORATION RENAL DIVISION

FDA 510(k) clearances by year

42007

42008

42009

22010

62011

32012

42013

42014

42015

22016

42017

42018

42019

82020

62021

102022

42023

62024

52025

22026

FDA listed device types

showing 8 of 96

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) 1Electrosurgical, Cutting & Coagulation & Accessories 1Dialyzer, High Permeability With Or Without Sealed Dialysate System 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K254265	Helion Viewer Suite	2026-05-27
US	K250135	WAVE Clinical Platform (2.0.000)	2026-01-16
US	K251745	Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)	2025-12-16
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