HomeChinaCARESTREAM HEALTHCARE INTERNATIONAL COMPANY LIMITED

CARESTREAM HEALTHCARE INTERNATIONAL COMPANY LIMITED

China · Shanghai
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Singapore, South Korea — 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
pendingnot queried
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
3listed device types
Class I 2Class II 1Class III 0
plus 4 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
6registered devices
Class I 5Class II 1
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
5 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
5device registrations
CLASS B 4CLASS C 1
KRSouth KoreaMFDS GMP
3GMP quality-system certificates
Import 3
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 States4 registration records, 0 510(k), 0 PMA, 12 excluded
Brazil6 confirmed, 7 excluded
Saudi Arabia0 confirmed, 2 excluded
Canada0 confirmed, 3 excluded
Manufacturer names merged into this page: Carestream Healthcare International Company, Ltd · CARESTREAM HEALTHCARE INTERNATIONAL COMPANY LIMITED

Company information

Country
China
City
Shanghai

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 listed device types

Generator, High-Voltage, X-Ray, Diagnostic 1Unit, Operative Dental 1System, X-Ray, Extraoral Source, Digital 1

Registration details (sample)

MarketIdentifierNameClass / date
BR80378750024DIGITALIZADOR DE IMAGENS RADIOLÓGICASClass I
BR80378750049IMPRESSORA LASER TRIMAXClass I
BR80378750050IMPRESSORA LASER CARESTREAM DRYVIEWClass I

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