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BAXTER CORPORATION

Belgium · Vienna

✓ Record-verifiedregistrations found in 4 markets

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

16listed device types

Class I 5Class II 10Class III 1

plus 53 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class II 2

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

8active device licences

Class II 8

18 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

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 States53 registration records, 1 510(k), 0 PMA, 39 excluded

Brazil2 confirmed, 12 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada8 confirmed, 9 excluded

Manufacturer names merged into this page: BAXTER SA · Baxter Limited · BAXTER AG · BAXTER CORPORATION · BAXTER LIMITED

FDA 510(k) clearances by year

11994 · K940147

FDA listed device types

showing 8 of 16

Block, Heating 1Dispenser, Liquid Medication 1System, Hemodialysis, Remote Accessories 1Regulator, Pressure, Gas Cylinder 1Adaptor, Ureteral Catheter 1Sealant, Polymerizing 1Filter, Infusion Line 1Stopcock, I.V. Set 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K940147	AUTO SYRINGE AS40A INFUSION PUMP	1994-04-15
BR	10068390235	EQUIPO PHOTO PARA MEDICAMENTO SENSIVEL A LUZ	Class II
BR	10068390249	Equipo revestido por Polietileno (PE)	Class II
CA	33622	TISSOMAT SPRAY DEVICE	Class II
CA	70045	EASYSPRAY PRESSURE REGULATOR	Class II
CA	4409	BURETROL FILTER	Class II

BAXTER CORPORATION

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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