Home›USA›STEREO OPTICAL COMPANY, INC

STEREO OPTICAL COMPANY, INC

USA · Chicago

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Taiwan, Australia, Israel — 5 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 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class I 3

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

3active ARTG entries

Class I 3

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

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 States5 registration records, 5 510(k), 0 PMA

Brazil3 confirmed, 0 excluded

Manufacturer names merged into this page: STEREO OPTICAL COMPANY LLC · STEREO OPTICAL COMPANY, INC

FDA 510(k) clearances by year

11984 · K843042

11986 · K863509

11988 · K875237

11991 · K904828

11993 · K924741

FDA listed device types

Chart, Visual Acuity 1Instrument, Measuring, Stereopsis 1Refractometer, Ophthalmic 1Stereoscope, Ac-Powered 1Tester, Color Vision 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K924741	OPTEC 3000	1993-04-06
US	K904828	OPTEC 2300 AFVT, ARMED FORCES VISION TESTER	1991-01-18
US	K875237	OPTEC 1000 DMV VISION TESTER MODIFY	1988-03-17
BR	10354340119	STEREO FLY TEST	Class I
BR	10354349018	teste de teller	Class I
BR	10354340099	DISPOSITIVOS DE TESTE VISUAL	Class I

STEREO OPTICAL COMPANY, INC

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies