Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008526732

FEI Number

3008526732

Entity Name

SYSMEX DO BRASIL IND E COM LTDA

City/State/Country

Sao Jose dos Pinhais Parana, BR

Establishment Address

Rua Joaquim Nabuco 615, Cidade Jardim, Sao Jose dos Pinhais Parana 83040-210, BR

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 CELLPACK DFL Cellpack Cellsheath CELLSHEATH CCS UF-CELLSHEATH XW pack D UF-CELLPACK CR UF-CELLPACK SF Cellsheath C CELLPACK DCL UF II PACK SED UF II Sheath pocH-pack D CELLPACK S RETSEARCH II UF II PACK-BAC CELLPACK DST

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
GIF	Diluent, Blood Cell	Hematology	Class 1	864.8200	2007-05-07

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
3010188738	SYSMEX CORPORATION ONO FACTORY	Ono Hyogo, JP
3006949423	SYSMEX REAGENTS AMERICA, INC.	Mundelein, IL, US
3005626422	Sysmex Europe SE	Neumunster Schleswig-Holstein, DE

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 3008526732. Last updated year: 2026. Please use registration number 3008526732 when referencing this establishment in official correspondence.