SYSMEX CORPORATION

Entity profile compiled from public source records

Public Record Profile Registrations: 14 510(k) filings: 0 Recalls: 0

Known Identifiers & Locations

FEI Numbers 1000515253, 3002759288, 3002808299, 3002808301, 3005626422, 3006949423, 3007701696, 3008526732, 3009495621, 3009711478, 3010188766, 3010421384, 3010960914, 3020704087
Owner Operator Numbers 9014170
Locations Covered Buffalo Grove, IL, US; KOBE Hyogo, JP; Kakogawa Hyogo, JP; Kobe Hyogo, JP; Lincolnshire, IL, US; Mundelein, IL, US; Neumunster Schleswig-Holstein, DE; Ono Hyogo, JP; Sao Jose dos Pinhais Parana, BR; Shiojiri Nagano, JP; Vernon Hills, IL, US

Registered Establishments (14)

Registration # Establishment Name Location Establishment Type(s) Action
1422681 SYSMEX AMERICA, INC. Mundelein, IL, US Manufacture Medical Device View Details
3002759288 SYSMEX CORPORATION KAKOGAWA FACTORY Kakogawa Hyogo, JP Manufacture Medical Device View Details
3005626422 Sysmex Europe SE Neumunster Schleswig-Holstein, DE Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
3006949423 SYSMEX REAGENTS AMERICA, INC. Mundelein, IL, US Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
3007701696 SYSMEX CORPORATION SEISHIN FACTORY Kobe Hyogo, JP Manufacture Medical Device View Details
3008526732 SYSMEX DO BRASIL IND E COM LTDA Sao Jose dos Pinhais Parana, BR Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
3009495621 Sysmex America, Inc. Buffalo Grove, IL, US Manufacture Medical Device View Details
3009711478 Sysmex America, Inc. Lincolnshire, IL, US Complaint File Establishment per 21 CFR 820.198 View Details
3010188738 SYSMEX CORPORATION ONO FACTORY Ono Hyogo, JP Manufacture Medical Device View Details
3010188766 Sysmex RA Co., LTD, Main Office Shiojiri Nagano, JP Manufacture Medical Device View Details
3010421384 SYSMEX CORPORATION KOBE Hyogo, JP Export Device to the United States But Perform No Other Operation on Device View Details
3010960914 SYSMEX CORPORATION i-SQUARE Kakogawa Hyogo, JP Manufacture Medical Device View Details
3020704087 Sysmex America, Inc. - Vernon Hills Vernon Hills, IL, US Manufacture Medical Device View Details
9613959 SYSMEX CORPORATION TECHNO PARK KOBE Hyogo, JP Develop Specifications But Do Not Manufacture At This Facility View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (0)

No recall records found for this entity.

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