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Cardinal Health K.K.

Japan · Fukuroi Shizuoka

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Singapore, South Korea, Israel — 7 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

523listed device types

Class I 234Class II 274Class III 7unclassified 8

plus 1,733 registration records and 59 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

79registered devices

Class I 25Class II 54

105 including historic records

SASaudi ArabiaSFDA

57registered imported devices

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

CACanadaMDALL

207active device licences

Class II 203Class III 4

512 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

11device registrations

CLASS B 11

KRSouth KoreaMFDS GMP

4GMP quality-system certificates

Import 4

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

5registrations

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 States1,733 registration records, 59 510(k), 0 PMA, 5 excluded

Brazil79 confirmed, 0 excluded

Saudi Arabia57 confirmed, 0 excluded

Canada207 confirmed, 1 excluded

Manufacturer names merged into this page: CARDINAL HEALTH 222 (THAILAND) LIMITED · Cardinal Health K.K. · Cardinal Health Mexico 244 S de RL de CV · Cardinal Health Canada Inc. · CARDINAL HEALTH CANADA INC. · CARDINAL HEALTH

FDA 510(k) clearances by year

11999

52005

52006

72007

42008

82009

72010

52011

42012

32013

12015

42016

12017

12018

12021

12022

12026

FDA listed device types

showing 8 of 523

Pad, Eye 1Device, Occlusion, Umbilical 1Dental Hygiene Kit 1Container, Specimen, Sterile 1Test, Luteinizing Hormone (Lh), Over The Counter 1Irrigation Kit (Wounds) 1Solvent, Adhesive Tape 1Breast Biopsy / Localization Tray 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253243	Cardinal Health Poly Reinforced Surgical Gown	2026-04-28
US	K221603	Kangaroo OMNI Enteral Feeding Pump (385400 );Kangaroo OMNI Feeding Set 500ml (B5FD );Kangaroo OMNI ENtelliSet 500ml (E5FD );Kangaroo OMNI Feeding Set 1000ml (B10FD );Kangaroo OMNI ENtelliSet 1000ml (E10FD );Kangaroo OMNI ENPlus Spike Set (BSPFD );Kangaroo OMNI ENtelliSet ENPlus Spike ( ESPFD );Kangaroo OMNI Feeding Set 500ml with Flush Bag ( B5FF);Kangaroo OMNI ENtelliSet 500ml with Flush Bag (E5FF);Kangaroo OMNI Feeding Set 1000ml with Flush Bag ( E10FF );Kangaroo OMNI	2022-12-20
US	K211765	Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse Gown	2021-11-23
BR	81356119017	Equipo de alimentação enteral Kangaroo OMNI	Class II
BR	81356112359	Equipo de Alimentação Spike e Bolsa Enfit	Class II
BR	81356112391	Eletrodos para ECG Kendall	Class I
SA	ME0000004570SFDAA00005	Kendall™	—
SA	ME0000004570SFDAA00007	Kendall™	—
CA	74406	THERMO FLASH INFRA-RED THERMOMETER	Class II
CA	1864	LATEX TUBING	Class II
CA	2470	AIR CUSHION FACE MASK	Class II

Cardinal Health K.K.

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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