HomeCARDINAL HEALTH DO BRASIL LTDA.

CARDINAL HEALTH DO BRASIL LTDA.

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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 476 registration records and 28 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
18registered devices
Class I 4Class II 14
32 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
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 States476 registration records, 28 510(k), 0 PMA, 30 excluded
Brazil18 confirmed, 3 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, INC. · CARDINAL HEALTH DO BRASIL LTDA.
Same-named companies — This database also contains companies with near-identical names: Cardinal Health-Medical Products and Services. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

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)

MarketIdentifierNameClass / date
USK221603Kangaroo 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
USK211765Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse Gown2021-11-23
USK170198Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested for Use with Chemotherapy Drugs (White)2017-06-15
BR10349000863Shiley Tubo de Traqueostomia Flexível Evac com Cânula Interna DescartáClass II
BR10349000865Shiley Tubo de Traqueostomia Flexível Evac com Manguito TaperGuard CânClass II
BR10349009012Shiley Tubo Flexível de Traqueostomia Adulto Sem CuffClass II
CA6387STERILE WATER FORTOPICAL IRRIGATIONClass II
CA6438CONTACT LENS SOLUTIONSClass II
CA6443NEBULIZER HEATERClass II

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