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Korea Optical Co., Ltd.

Korea, Republic · Daejeon

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Saudi Arabia, Taiwan, Russia — 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

4listed device types

Class I 4Class II 0Class III 0

plus 4 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

3registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

1active registrations

Class 2a 1

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 States4 registration records, 2 510(k), 0 PMA, 519 excluded

Brazil0 confirmed, 32 excluded

Saudi Arabia3 confirmed, 79 excluded

Canada0 confirmed, 14 excluded

Manufacturer names merged into this page: Korea Optical Co., Ltd. · KOREA OPTICAL INDUSTRY COOP. · Korea Optical CO.LTD

FDA 510(k) clearances by year

21987 · K871961

FDA listed device types

Lens, Spectacle, Non-Custom (Prescription) 1Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) 1Sunglasses (Non-Prescription Including Photosensitive) 1Frame, Spectacle 1

Market	Identifier	Name	Class / date
US	K871961	MULTIPLE SPECTACLE LENS	1987-06-03
US	K871649	CLASSIC 70 LENS	1987-05-29
SA	ME0000013049SFDAA00001	Clex	—
SA	ME0000013049SFDAA00001	Clex	—

Korea Optical Co., Ltd.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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