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STEPHENS INSTRUMENTS, INC

USA · Lexington

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Israel — 7 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

53listed device types

Class I 51Class II 1Class III 0unclassified 1

plus 56 registration records and 6 510(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

3 including historic records

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

29active ARTG entries

Class I 27IIb 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States56 registration records, 6 510(k), 0 PMA, 2 excluded

Saudi Arabia3 confirmed, 0 excluded

Manufacturer names merged into this page: STEPHENS INSTRUMENTS, INC · USIOL INC. ALSO TRADING AS STEPHENS INSTRUMENTS · STEPHENS INSTRUMENTS

FDA 510(k) clearances by year

52002 · K022840

12014 · K140352

FDA listed device types

showing 8 of 53

Ruler, Nearpoint (Punctometer) 1Set, Lens, Trial, Ophthalmic 1Forceps 1Container, Specimen, Sterile 1Trypan Blue 1Gauge, Lens, Ophthalmic 1Hook, Ophthalmic 1Marker, Ocular 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K140352	VERAPLUG	2014-11-13
US	K022840	STEPHENS DISPOSABLE SCISSORS	2002-11-01
US	K022836	STEPHENS DISPOSABLE SPECULUM	2002-11-01
SA	ME0000002589SFDAA00002	SPECULUMS	—
SA	ME0000002589SFDAA00003	STEPHENS Scissors	—

STEPHENS INSTRUMENTS, INC

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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