Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2086725

FEI Number

3002698356

Entity Name

HORIBA INSTRUMENTS INCORPORATED

City/State/Country

IRVINE, CA, US

Establishment Address

9755 Research Dr, IRVINE, CA 92618, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

HORIBA INSTRUMENTS INCORPORATED (DBA) HORIBA Medical (Owner Number: 10083022)

Owner / Operator Contact Address

9755 Research Drive, Irvine, CA 92618, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

LiteDM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2021-10-20

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

HORIBA INSTRUMENTS INCORPORATED (DBA) HORIBA Medical

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1827821	HORIBA INSTRUMENTS INCORPORATED	Canton, MI, US

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-05	ABX Diagnostics Inc	2	Automated Differential Cell Counter
Z-0003-05	ABX Diagnostics Inc	2	Automated Differential Cell Counter

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3002725312	AMERICAN PORTWELL TECHNOLOGY, INC.	Fremont, CA, US
3007832484	JWP MANUFACTURING	Santa Clara, CA, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2086725. Last updated year: 2026. Please use registration number 2086725 when referencing this establishment in official correspondence.