HomeKorea, RepublicUNICOS CO., LTD.

UNICOS CO., LTD.

Korea, Republic · Daejeon
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Israel, Russia — 8 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
5listed device types
Class I 5Class II 0Class III 0
plus 5 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class II 2
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
4registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
1active device licences
Class II 1
TWTaiwanTFDA
2valid device licences
Class I 2
SGSingaporeHSA SMDR
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
4registrations
RURussiaRoszdravnadzor
11active registrations
Class 1 5Class 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 States5 registration records, 0 510(k), 0 PMA
Brazil2 confirmed, 0 excluded
Saudi Arabia4 confirmed, 0 excluded
Canada1 confirmed, 0 excluded
Manufacturer names merged into this page: UNICOS CO., LTD. · UNICOS CO., LTD

Company information

Country
Korea, Republic
City
Daejeon

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 listed device types

Chart, Visual Acuity 1Refractor, Manual, Non-Powered, Including Phoropter 1Projector, Ophthalmic 1Refractometer, Ophthalmic 1Instrument, Measuring, Lens, Ac-Powered 1

Registration details (sample)

MarketIdentifierNameClass / date
BR80047309162REFRATOR DIGITALClass II
BR80047309164REFRATÔMETRO/QUERATÔMETRO AUTOMÁTICOClass II
SAME0000018939SFDAA00003LCD chart
SAME0000018939SFDAA00001Ophthalmic projector
CA90343AUTO REFRACTO-KERATOMETERClass II

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