Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007701696

FEI Number

3007701696

Entity Name

SYSMEX CORPORATION SEISHIN FACTORY

City/State/Country

Kobe Hyogo, JP

Establishment Address

4-3-2 Takatsukadai, Nishi-ku, Kobe Hyogo 651-2271, 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

K070910

PMA Number

N/A

All Registered Proprietary Names

UF-CALIBRATOR CA CAL S UF-1000i

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JIW	Calibrator, Surrogate	Clinical Chemistry	Class 2	862.1150	2018-05-08
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2012-02-20
LKM	Counter, Urine Particle	Hematology	Class 2	864.5200	2008-03-17

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
3010188738	SYSMEX CORPORATION ONO FACTORY	Ono Hyogo, JP
3006949423	SYSMEX REAGENTS AMERICA, INC.	Mundelein, IL, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K924453	Organon Teknika Corp.	MULTI-CHANNEL DISCRETE ANALYZER (MDA-180)	1992-12-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0032-06	BIOMERIEUX, INC.	2	VeriCal Calibrator Set
Z-0042-05	Dade Behring Inc. Rte 896, Glasgow Business Community	2	DispoSystem for BCT System.Model number OVFR03. Multipurpose System for in vitro coagulation studies.
Z-0043-05	bioMerieux	2	The MDA system with MDA Antithrombin III MDA Heparin
Z-0736-04	Instrumentation Laboratory Co.	2	ACL Futura Instrument Analyzer
Z-0737-04	Instrumentation Laboratory Co.	2	ACL Advance Instrument Analyzer

Similar Registrations

Registration Number	Establishment Name	Location
9613959	SYSMEX CORPORATION TECHNO PARK	KOBE Hyogo, JP
3009711478	Sysmex America, Inc.	Lincolnshire, IL, US
2517506	SIEMENS HEALTHCARE DIAGNOSTICS INC.	NEWARK, DE, US
3011310576	ARKRAY INDUSTRY INC.	Sto. Tomas Batangas, PH
1219738	HiArc	Merrimack, NH, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007701696. Last updated year: 2026. Please use registration number 3007701696 when referencing this establishment in official correspondence.