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Cardinal Health Ireland Manufacturing Limited

Ireland · Tullamore Offaly

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, South Korea — 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

181listed device types

Class I 88Class II 87Class III 2unclassified 4

plus 480 registration records and 28 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

18registered devices

Class I 4Class II 14

19 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

91active device licences

Class II 90Class III 1

168 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

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 States480 registration records, 28 510(k), 0 PMA, 29 excluded

Brazil18 confirmed, 4 excluded

Saudi Arabia0 confirmed, 2 excluded

Canada91 confirmed, 6 excluded

Manufacturer names merged into this page: Cardinal Health K.K. · CARDINAL HEALTH · Cardinal Health · Cardinal Health Ireland Manufacturing Limited · CARDINAL HEALTH, INC.

FDA 510(k) clearances by year

12006

32007

12008

62009

42010

42011

22012

12013

32016

12017

12021

12022

FDA listed device types

showing 8 of 181

Pad, Eye 1Device, Occlusion, Umbilical 1Container, Specimen, Sterile 1Solvent, Adhesive Tape 1Board, Arm (With Cover), Sterile 1Needle, Aspiration And Injection, Disposable 1Garment, Protective, For Incontinence 1Bag, Ice 1

Registration details (sample)

Market	Identifier	Name	Class / date
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
US	K170198	Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested for Use with Chemotherapy Drugs (White)	2017-06-15
BR	10349000863	Shiley Tubo de Traqueostomia Flexível Evac com Cânula Interna Descartá	Class II
BR	10349000865	Shiley Tubo de Traqueostomia Flexível Evac com Manguito TaperGuard Cân	Class II
BR	10349009012	Shiley Tubo Flexível de Traqueostomia Adulto Sem Cuff	Class II
CA	6387	STERILE WATER FORTOPICAL IRRIGATION	Class II
CA	6438	CONTACT LENS SOLUTIONS	Class II
CA	6443	NEBULIZER HEATER	Class II

Cardinal Health Ireland Manufacturing Limited

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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