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CARDINAL HEALTH 200, LLC ALSO TRADING AS CARDINAL HEALTH

USA · Waukegan

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 10 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

491listed device types

Class I 231Class II 251Class III 1unclassified 8

plus 925 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

60registered devices

Class I 21Class II 39

72 including historic records

SASaudi ArabiaSFDA

57registered imported devices

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

CACanadaMDALL

52active device licences

Class II 52

254 including historic records

TWTaiwanTFDA

9valid device licences

Class I 6Class II 3

SGSingaporeHSA SMDR

10device registrations

CLASS B 8CLASS C 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

71active ARTG entries

Class I 35IIa 15IIb 4Class Im (measuring) 1Class Is (sterile) 16

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

43registrations

RURussiaRoszdravnadzor

2active registrations

Class 2a 2

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 States925 registration records, 4 510(k), 0 PMA

Brazil60 confirmed, 0 excluded

Saudi Arabia57 confirmed, 0 excluded

Canada52 confirmed, 0 excluded

Manufacturer names merged into this page: Cardinal Health 200, LLC · CARDINAL HEALTH 200, LLC · CARDINAL HEALTH 200, LLC ALSO TRADING AS CARDINAL HEALTH · Cardinal Health 200 LLC

FDA 510(k) clearances by year

12006 · K061308

12015 · K150151

12016 · K151778

12026 · K253243

FDA listed device types

showing 8 of 491

Electrosurgical, Cutting & Coagulation & Accessories 1Glossopharyngeal Anesthesia Kit 1Forensic Evidence Sexual Assault Kit 1Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection 1Drape, Microscope, Ophthalmic 1Radiology-Diagnostic Kit 1Monitor, Pressure, Intrauterine 1Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253243	Cardinal Health Poly Reinforced Surgical Gown	2026-04-28
US	K151778	Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating	2016-03-24
US	K150151	SmartGownTM surgical gown	2015-05-21
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	95299	DOVER FOLEY TRAYS	Class II
CA	103465	CONVERTORS GENERAL ENDOSCOPY PACK	Class II
CA	105322	ST ULTRASOUND GEL	Class II

CARDINAL HEALTH 200, LLC ALSO TRADING AS CARDINAL HEALTH

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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