HomeUSAOPTOVUE, INC.

OPTOVUE, INC.

USA · San Jose
✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 9 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 1Class II 3Class III 0
plus 14 registration records and 16 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class II 2
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
7 including historic records
TWTaiwanTFDA
4valid device licences
Class II 4
SGSingaporeHSA SMDR
6device registrations
CLASS B 6
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
IIa 1
HKHong KongMDACS
1valid listings
Class II 1
ILIsraelAMAR
4registrations
RURussiaRoszdravnadzor
6active registrations
Class 2a 6
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 States14 registration records, 16 510(k), 0 PMA
Brazil2 confirmed, 0 excluded
Manufacturer names merged into this page: OPTOVUE, INC.

Company information

Country
USA
City
San Jose

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
12007
32010
22011
12012
32013
12014
12016
12017
12018
12022

FDA listed device types

Ophthalmoscope, Ac-Powered 1Tomography, Optical Coherence 1Camera, Ophthalmic, Ac-Powered 1Topographer, Corneal, Ac-Powered 1

Registration details (sample)

MarketIdentifierNameClass / date
USK222166SOLIX2022-11-09
USK180660Avanti2018-06-08
USK163475iVue2017-06-09
BR80192010055TOMÓGRAFO DE COERÊNCIA OPTICAClass II
BR80117580906SOLIXClass II

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