Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010960914

FEI Number

3010960914

Entity Name

SYSMEX CORPORATION i-SQUARE

City/State/Country

Kakogawa Hyogo, JP

Establishment Address

262-11 Mizuashi, Noguchicho, Kakogawa Hyogo 675-0019, 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

CS-2500 CA-7000 SP-50 SP-1000i SP-10 Pneumatic Unit (PU-17) XN-11 Automated Blood Coagulation Analyzer CN-6000 Automated Blood Coagulation Analyzer CN-3000 CS-5100 Option Sampler SA-90 XS-1000i sampler (OPSU-11) HST-N SA-31 Barcode Terminal (BT-40) ST-40 SA-30 AlphaN-SPSU CV-65 RB-10 Pneumatic Unit (PU-17) SA-02 RU-10 ST-42 SA-10 SA-20 SA-21 ST-41 CV-60 SA-01 CF-70 CV-50 RR-20 RR-10 COMPLETE OPSU-6 CV-55 AlphaN-XESU RU-21 TS-10 RU-20 CV-70 TU-40 CF-60 SA-51 U-RDU CV-11 TH-11 BT-50 TS-01 Automated Tube Sorter TA-01 Automated Tube Archiver Urine Sample Transportation Unit ST-10 Urine Sample Transportation Unit ST-11 Urine Sample Transportation Unit ST-12 Sysmex XR-Series (XR-10) Automated Hematology Analyzer Sysmex XR-Series (XR-20) Automated Hematology Analyzer UD-10 Sysmex XN-10 Automated Hematology Analyzer XN-20 XN-10 UF-5000 Urinalysis Data Manager (UDM) Sysmex WAM (Work Area Management)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2016-02-03
GKP	Instrument, Coagulation, Automated	Hematology	Class 2	864.5400	2012-02-20
KPA	Slide Stainer, Automated	Pathology	Class 1	864.3800	2012-03-18
GLE	Mixer, Blood Tube	Clinical Chemistry	Class 1	862.2050	2016-12-01
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2014-12-17
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2025-07-18
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2016-01-18
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2011-07-06
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2025-11-18
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2025-11-18
JOY	Device, Automated Cell-Locating	Hematology	Class 2	864.5260	2018-12-04
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2021-08-02
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2012-10-29
LKM	Counter, Urine Particle	Hematology	Class 2	864.5200	2018-05-04
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2011-12-30

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
K961991	Instrumentation Laboratory CO	ACL 6000 SYSTEM (ACL 6000)	1996-09-04
K910283	Danam Electronics	DANAM DATACELL-18	1991-04-12
K102064	Becton, Dickinson & CO	BD FACS SAMPLE PREP ASSISTANT III (SPA III)	2011-03-07

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

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9610806	Siemens Healthcare Diagnostics Products GmbH	MARBURG Hesse, DE
3005792925	TEM Innovations GmbH	Munich Bavaria, DE
3020704087	Sysmex America, Inc. - Vernon Hills	Vernon Hills, IL, US
1217183	INSTRUMENTATION LABORATORY CO.	Bedford, MA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010960914. Last updated year: 2026. Please use registration number 3010960914 when referencing this establishment in official correspondence.