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Carefusion, Inc.

USA · Vernon Hills

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Singapore, South Korea, Australia, Hong Kong, Israel — 8 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

7listed device types

Class I 0Class II 7Class III 0

plus 34 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

12registered devices

Class I 9Class II 3

14 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

37active device licences

Class II 29Class III 8

70 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

6device registrations

CLASS B 3CLASS C 3

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

139active ARTG entries

Class I 88IIa 35IIb 8Class Im (measuring) 6Class Is (sterile) 2

HKHong KongMDACS

3valid listings

Class II 2Class III 1

ILIsraelAMAR

14registrations

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 States34 registration records, 3 510(k), 0 PMA, 11 excluded

Brazil12 confirmed, 0 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada37 confirmed, 4 excluded

Manufacturer names merged into this page: CAREFUSION

FDA 510(k) clearances by year

22016 · K153234

12020 · K193088

FDA listed device types

Stopcock, I.V. Set 1Set, Blood Transfusion 1Syringe, Piston 1Set, I.V. Fluid Transfer 1Set, Administration, Intravascular 1Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System 1Needle, Hypodermic, Single Lumen 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K193088	MaxZero Extension Sets with Needle-Free Connector(s)	2020-10-23
US	K153234	AirLife Adult Heated Wire Circuit	2016-07-07
US	K151959	AirLife Infant Single Limb Heated Wire Circuit	2016-01-20
BR	10033430878	Frasco de Vácuo PleurX	Class I
BR	10033430793	Garrafa de vácuo Pleurx com tubo de drenagem	Class I
BR	10033430732	BD ChloraPrep Swabstick	Class I
CA	5847	LOW FLOW NITROUS OXIDE BLENDER	Class II
CA	5848	BIRD 6500 AIR COMPRESSOR	Class II
CA	5852	BIRD HEATED HUMIDIFIER	Class II

Carefusion, Inc.

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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