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CARESTREAM MEDICAL

USA · Sanford
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 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
4listed device types
Class I 0Class II 4Class III 0
plus 5 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
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
2active device licences
Class II 2
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 States5 registration records, 1 510(k), 0 PMA, 11 excluded
Brazil0 confirmed, 8 excluded
Saudi Arabia0 confirmed, 2 excluded
Canada2 confirmed, 3 excluded
Manufacturer names merged into this page: CARESTREAM MEDICAL · CARESTREAM MEDICAL ULC
Same-named companies — This database also contains companies with near-identical names: CARESTREAM MEDICAL ULC. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Sanford

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

12015 · K151924

FDA listed device types

Mixer, Breathing Gases, Anesthesia Inhalation 1Apparatus, Gas-Scavenging 1Platelet And Plasma Separator For Bone Graft Handling 1Apparatus, Suction, Operating-Room, Wall Vacuum Powered 1

Registration details (sample)

MarketIdentifierNameClass / date
USK151924Q-Rad Radiographic System with Auto-Tracker Option2015-08-07
CA87750HUMICARE 200NClass II
CA87752PATIENT SET FOR R100 HFOV AND HUMICARE 200N (DISPOSABLE)Class II

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