HomeIsraelNotal Vision , Ltd.

Notal Vision , Ltd.

Israel · Tel-Aviv
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Israel — 3 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 1Class II 1Class III 0
plus 2 registration records and 4 510(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
1 including historic records
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 States2 registration records, 4 510(k), 0 PMA
Manufacturer names merged into this page: NOTAL VISION LTD.

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.

Business registration

Legal name
NOTAL VISION LTD
Company number
512995283
Registration status
Active
Incorporated
2000-08-13

Business registration data from Israel Companies Registrar, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12002 · K014044
12005 · K050350
12009 · K091579
12024 · DEN230043

FDA listed device types

Perimeter, Automatic, Ac-Powered 1Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device 1

Registration details (sample)

MarketIdentifierNameClass / date
USDEN230043Notal Vision Home Optical Coherence Tomography (OCT) System2024-05-15
USK091579FORESEE HOME2009-12-23
USK050350THE NOTAL VISION PREVIEW PREFERENTIAL HYPERACUITY PERIMETER (PREVIEW PHP)2005-04-29

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