HomeIsraelSmart Medical Systems , Ltd.

Smart Medical Systems , Ltd.

Israel · Ra'Anana
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Australia, Israel — 4 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
2listed device types
Class I 0Class II 2Class III 0
plus 5 registration records and 9 510(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
0active device licences
5 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
5active ARTG entries
Class I 1IIa 4
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
4registrations
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, 9 510(k), 0 PMA, 61 excluded
Brazil0 confirmed, 7 excluded
Saudi Arabia0 confirmed, 1 excluded
Canada0 confirmed, 11 excluded
Manufacturer names merged into this page: SMART MEDICAL SYSTEMS LTD. · SMART MEDICAL SYSTEMS LTD

Company information

Country
Israel
City
Ra'Anana

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
22010 · K102616
22011 · K111760
12012 · K112106
22020 · K202469
12022 · K220158

FDA listed device types

Endoscope Channel Accessory 1Colonoscope And Accessories, Flexible/Rigid 1

Registration details (sample)

MarketIdentifierNameClass / date
USK220158G-EYE System2022-04-11
USK202469G-EYE System2020-10-26
USK192588G-EYE System2020-04-15

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