SYSMEX AMERICA, INC.

FDA Device Registration & Listing · Mundelein, IL, US · Registration 1422681

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1422681
FEI Number
1000515253
Entity Name
SYSMEX AMERICA, INC.
City/State/Country
Mundelein, IL, US
Establishment Address
ONE SYSMEX WAY, Mundelein, IL 60060, US
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
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Urinalysis Data Manager (UDM) Sysmex WAM (Work Area Management)

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 2011-12-30

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
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
3005626422 Sysmex Europe SE Neumunster Schleswig-Holstein, DE

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1422681. Last updated year: 2026. Please use registration number 1422681 when referencing this establishment in official correspondence.
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