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Home›Israel›S.D. Sight Diagnostics , Ltd.

S.D. Sight Diagnostics , Ltd.

Israel · Tel Aviv
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, 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
2510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
3registered devices
Class II 3
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 1Class III 1
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
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 States0 registration records, 2 510(k), 0 PMA, 13 excluded
Brazil3 confirmed, 2 excluded
Canada2 confirmed, 3 excluded
Manufacturer names merged into this page: S.D. SIGHT DIAGNOSTICS LTD. · S.D. SIGHT DIAGNOSTICSLTD
Same-named companies — This database also contains companies with near-identical names: Sight Diagnostics , Ltd.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Israel
City
Tel Aviv

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

12019 · K190898
12022 · K211840

Registration details (sample)

MarketIdentifierNameClass / date
USK211840Sight OLO2022-05-09
USK190898Sight OLO2019-11-01
BR80686360303CBC Test KitClass II
BR80686360299Sight OLO-E1Class II
BR80686360300OLO Control KitClass II
CA106000SIGHT OLOClass II
CA106263SIGHT OLO-E1Class III

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