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OCULAR INSTRUMENTS, INC.

USA · Bellevue

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, 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

9listed device types

Class I 6Class II 3Class III 0

plus 43 registration records and 50 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

13registered devices

Class I 8Class II 5

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

SASaudi ArabiaSFDA

7registered imported devices

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

CACanadaMDALL

0active device licences

4 including historic records

TWTaiwanTFDA

6valid device licences

Class I 6

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

13active ARTG entries

Class I 8Class Is (sterile) 5

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 States43 registration records, 50 510(k), 0 PMA, 15 excluded

Brazil13 confirmed, 1 excluded

Saudi Arabia7 confirmed, 0 excluded

Canada0 confirmed, 3 excluded

Manufacturer names merged into this page: OCULAR INSTRUMENTS, INC. · OCULAR INSTRUMENTS INC.

FDA 510(k) clearances by year

11984

11985

121986

71987

51988

61989

11990

91991

21992

41994

12001

12002

FDA listed device types

showing 8 of 9

Keratoprosthesis, Temporary Implant, Surgical Use 1Tonometer, Manual 1Lens, Contact, Polymethylmethacrylate, Diagnostic 1Ring, Ophthalmic (Flieringa) 1Lens, Condensing, Diagnostic 1Microscope, Operating & Accessories, Ac-Powered, Ophthalmic 1Prism, Gonioscopic 1Tray, Surgical, Instrument 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K014170	STAURENGHI WIDE FIELD SCANNING LASER LENS	2002-03-04
US	K012096	DISPOSABLE VITRECTOMY LENS	2001-08-24
US	K933976	MANDELKORN SUTURE LYSIS LENS	1994-11-08
BR	81045609001	Lentes Oftálmicas Indirect Diagnostic / Laser Lenses	Class II
BR	81045609002	Lentes Oftálmicas Diagnostic Lenses	Class II
BR	81045609003	Lentes Oftálmicas Surgical Lenses	Class II
SA	ME0000001247SFDAA00002	Laser Lenses	—
SA	ME0000001296SFDAA00002	Surgical Lenses	—

OCULAR 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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