Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003244710

FEI Number

3003244710

Entity Name

Beckman Coulter Biotechnology (Suzhou) Co., Ltd

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

Units 101, 201, 301, Building 4 No. 218 Sangtian Street, BioBAY Sangtian Island, Suzhou Industrial Park, Suzhou Jiangsu 215025, CN

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

BECKMAN COULTER, INC. (Owner Number: 2050012)

Owner / Operator Contact Address

250 S. Kraemer Blvd, --, Brea, CA 92821, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K232600

PMA Number

N/A

All Registered Proprietary Names

DxFLEX Flow Cytometer ClearLLab 10C T Cell Tube, ClearLLab 10C B Cell Tube, ClearLLab 10C M1 Cell Tube, ClearLLab M2 Cell Tube

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PWD	Flow Cytometric Test System For Hematopoietic Neoplasms	Hematology	Class 2	864.7010	2023-12-13
OYE	Flow Cytometric Reagents And Accessories.	Hematology	Class 2	864.5220	2023-12-13

Official Correspondent

No official correspondent registered.

US Agent Details

Ian Pilcher Business: Beckman Coulter, Inc. Email: ipilcher@beckman.com Phone: (443) 3506459

Related Public Records

Same Entity

BECKMAN COULTER, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004198394	BECKMAN COULTER, INC.	INDIANAPOLIS, IN, US
3021394862	Beckman Coulter Biomedical GmbH	Baierbrunn Bavaria, DE
3008629785	Beckman Coulter, Inc.	Hebron, KY, US
3006677029	Beckman Coulter Biomedical GmbH	Munchen Bavaria, DE
3007750372	Beckman Coulter Distribution B.V.	Woerden Utrecht, NL

Similar Registrations

Registration Number	Establishment Name	Location
1061932	BECKMAN COULTER, INC.	Miami, FL, US
3016954941	Beckman Coulter India Private Limited	Bengaluru (Bangalore) Urban Karnataka, IN
1017835	BECKMAN COULTER, INC.	HIALEAH, FL, US
3027394506	Becton, Dickinson and Company, BD Biosciences	Milpitas, CA, US
1064130	CLINICAL DIAGNOSTIC SOLUTIONS, INC.	PLANTATION, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003244710. Last updated year: 2026. Please use registration number 3003244710 when referencing this establishment in official correspondence.