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OCUJECT, LLC

USA · Newport Beach

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 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

7listed device types

Class I 1Class II 6Class III 0

plus 8 registration records and 8 510(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

3 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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 States8 registration records, 8 510(k), 0 PMA

Manufacturer names merged into this page: OCUJECT, LLC · OCUJECT LLC

FDA 510(k) clearances by year

12017 · K170768

32021 · K212544

32023 · K233343

12024 · K242956

FDA listed device types

Low Dead Space Needle, Single Lumen, Hypodermic 1Ophthalmic Needle 1Low Dead Space Piston Syringe 1Syringe, Piston 1Needle, Hypodermic, Single Lumen 1Ophthalmic Syringe 1Needle, Aspiration And Injection, Disposable 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K242956	LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle	2024-10-25
US	K233343	SteriCap Safety Needle; VitreJect Safety Needle	2023-11-27
US	K230959	VitreJect® Needle; OcuSafe® Needle	2023-09-14

OCUJECT, LLC

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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