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Cerner Corporation

USA · Kansas City

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Singapore, Australia — 5 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

6listed device types

Class I 2Class II 4Class III 0

plus 8 registration records and 8 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class I 2Class II 1

4 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

1 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

2device registrations

CLASS B 1CLASS C 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IIb 1

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 States8 registration records, 8 510(k), 0 PMA, 1 excluded

Brazil3 confirmed, 0 excluded

Manufacturer names merged into this page: Cerner Corporation · CERNER CORPORATION

FDA 510(k) clearances by year

11996 · K955000

12000 · K000770

12007 · K070394

32009 · K093134

12012 · K121758

12015 · K151672

FDA listed device types

System, Network And Communication, Physiological Monitors 1Transmitters And Receivers, Physiological Signal, Radiofrequency 1Blood Establishment Computer Software And Accessories 1System, Monitoring, Perinatal 1Monitor, Bed Patient 1System, Digital Image Communications, Radiological 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K151672	Cerner CareAware Event Management	2015-12-21
US	K121758	CERNER FETALINK+(VERSION1.0)	2012-10-09
US	K093134	CERNER CAREAWARE IBUS	2009-11-27
BR	80117580925	CAREAWARE EVENT MANAGEMENT	Class II
BR	80117580294	CAREAWARE MULTIMEDIA ARCHIVE	Class I
BR	80117589011	CERNER CAREAWARE IBUS	Class I

Cerner Corporation

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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