Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010188738

FEI Number

3002808299

Entity Name

SYSMEX CORPORATION ONO FACTORY

City/State/Country

Ono Hyogo, JP

Establishment Address

17 Takumidai, Ono Hyogo 675-1322, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SYSMEX CORPORATION (Owner Number: 9014170)

Owner / Operator Contact Address

4-4-4 TAKATSUKADAI, NISHI-KU, KOBE, JP-NOTA 651-2271, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CELLPACK DFL Cellpack Cellsheath CELLSHEATH CCS UF-CELLSHEATH XW pack D UF-CELLPACK CR UF-CELLPACK SF Cellsheath C CELLPACK DCL UF II PACK SED UF II Sheath pocH-pack D CELLPACK S RETSEARCH II UF II PACK-BAC CELLPACK DST UFII SEARCH-SED UFII SEARCH-BAC UF-Fluorocell CR UF-Fluorocell SF SB Cuvette Reaction Tube Cuvette

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GIF	Diluent, Blood Cell	Hematology	Class 1	864.8200	2007-05-07
GJH	Stain, Reticulocyte	Hematology	Class 1	864.1850	2012-08-17
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2024-03-07

Official Correspondent

No official correspondent registered.

US Agent Details

Simon C. Shorter Business: SYSMEX AMERICA, INC Email: shorters@sysmex.com Phone: (408) 8380220

Related Public Records

Same Entity

SYSMEX CORPORATION

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1422681	SYSMEX AMERICA, INC.	Mundelein, IL, US
3009495621	Sysmex America, Inc.	Buffalo Grove, IL, US
3008526732	SYSMEX DO BRASIL IND E COM LTDA	Sao Jose dos Pinhais Parana, BR
3006949423	SYSMEX REAGENTS AMERICA, INC.	Mundelein, IL, US
3005626422	Sysmex Europe SE	Neumunster Schleswig-Holstein, DE

Similar Registrations

Registration Number	Establishment Name	Location
1319681	ORTHO-CLINICAL DIAGNOSTICS, INC.	Rochester, NY, US
3000148879	HORIBA ABX SAS	MONTPELLIER Herault, FR
3009963993	AZER SCIENTIFIC, INC.	Morgantown, PA, US
3006949423	SYSMEX REAGENTS AMERICA, INC.	Mundelein, IL, US
3010421384	SYSMEX CORPORATION	KOBE Hyogo, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010188738. Last updated year: 2026. Please use registration number 3010188738 when referencing this establishment in official correspondence.