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GOOD-LITE CO.

USA · Elgin

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Taiwan, 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

16listed device types

Class I 16Class II 0Class III 0

plus 16 registration records and 3 510(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

TWTaiwanTFDA

3valid device licences

Class I 3

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

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 States16 registration records, 3 510(k), 0 PMA, 11 excluded

Saudi Arabia0 confirmed, 4 excluded

Manufacturer names merged into this page: GOOD-LITE CO.

FDA 510(k) clearances by year

31984 · K842515

FDA listed device types

showing 8 of 16

Set, Lens, Trial, Ophthalmic 1Distometer 1Reader, Prism, Ophthalmic 1Illuminator, Color Vision Plate 1Chart, Visual Acuity 1Sunglasses (Non-Prescription Including Photosensitive) 1Screen, Tangent, Felt (Campimeter) 1Exophthalmometer 1

Market	Identifier	Name	Class / date
US	K842515	SURGICAL HEADLIGHT	1984-08-02
US	K842135	HI-LO FLOOR STANDING EXAM. LIGHT	1984-07-06
US	K833956	DOT VISUAL ACVITY TEST 2000	1984-01-04

GOOD-LITE CO.

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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