Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005626422

FEI Number

3005626422

Entity Name

Sysmex Europe SE

City/State/Country

Neumunster Schleswig-Holstein, DE

Establishment Address

Mainstrasse 7, Neumunster Schleswig-Holstein D-24539, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

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

Lysercell WPC Lysercell WNR Lysercell WDF Sulfolyser Stromatolyser-4DS XW pack L Stromatolyser-IM Stromatolyser-4DL Stromatolyser-3WP Stromatolyser-WH Stromatolyser-NR Stromatolyser-FB pocH-pack L Stromatolyser-NR(L) Lysercell WDF II STROMATOLYSER NR (S) FLUOROCELL WPC FLUOROCELL WNR FLUOROCELL WDF FLUOROCELL PLT FLUOROCELL RET CA CLEAN I CELLCLEAN CELLCLEAN AUTO Concentrated phosphate buffer for SP pH 6.6 Concentrated phosphate buffer for SP pH 7.2 Concentrated phosphate buffer for SP pH 6.8 Concentrated phosphate buffer for SP pH 7 XW CELLCLEAN CyFlow CLEAN CA CLEAN II CN-COAGWASHER

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GGK	Products, Red-Cell Lysing Products	Hematology	Class 1	864.8540	2007-05-07
KQC	Stains, Hematology	Hematology	Class 1	864.1850	2012-06-04
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	1998-05-06

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
K791007	Bioscientific	STAT DIFF STAIN	1979-08-03

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0043-2012	EMD Chemicals Inc.	1	Harleco Giemsa Stain 25 gram glass bottle, Item #228-12 Manufactured for EMD Chemicals Inc., Gibbstown, NJ 08027 1-800-222-0342 Made in India. The product is a Class I, IVD dye and chemical stain for use in Hematology.

Similar Registrations

Registration Number	Establishment Name	Location
3008629785	Beckman Coulter, Inc.	Hebron, KY, US
3016764932	ZHEJIANG GENE SCIENCE CO., LTD	shaoxing Zhejiang, CN
3013059683	ATSI Logistics Center ApS	GLOSTRUP Hovedstaden, DK
9613959	SYSMEX CORPORATION TECHNO PARK	KOBE Hyogo, JP
1064608	JAS Diagnostics/Drew Scientific	Plantation, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005626422. Last updated year: 2026. Please use registration number 3005626422 when referencing this establishment in official correspondence.