Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021394862

FEI Number

3021394862

Entity Name

Beckman Coulter Biomedical GmbH

City/State/Country

Baierbrunn Bavaria, DE

Establishment Address

Kuehler Weg 1, Baierbrunn Bavaria 82065, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

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

N/A

PMA Number

N/A

All Registered Proprietary Names

AutoMate 2500 Sample Processing System AutoMate 1200 Sample Processing System AutoMate 2550 Sample Processing System AutoMate 1250 Sample Processing System ODL25250 AutoMate 2500 LAB INSTRUMENT ODL25255 AutoMate 2550 LAB INSTRUMENT A18894 Automate 800 Sample Processing System ODL25120 AutoMate 1200 LAB INSTRUMENT A18896 Automate 600 Sample Processing System ODL25125 AutoMate 1250 LAB INSTRUMENT Command Central Kaluza C Perpetual License (PN C10574) Kaluza C Flow Cytometry Software (PN C21166) Kaluza C Single Use 1 Year License (PN C10575) Kaluza C 10 User Network (PN C10576) DxOne Workflow Manager Kaluza C 5 User Network (PN C10577) REMISOL ADVANCE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JQP	Calculator/Data Processing Module, For Clinical Use	Clinical Chemistry	Class 1	862.2100	2000-10-04

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
3008629785	Beckman Coulter, Inc.	Hebron, KY, US
3006677029	Beckman Coulter Biomedical GmbH	Munchen Bavaria, DE
3003244710	Beckman Coulter Biotechnology (Suzhou) Co., Ltd	Suzhou Jiangsu, CN
3007750372	Beckman Coulter Distribution B.V.	Woerden Utrecht, NL

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K781173	Instrumentation Laboratory CO	COMPUTER INTERFACE IL 814	1978-09-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-04	Misys Healthcare Systems	1	Calculator/Data Processing Module for Clinical Use
Z-0026-2025	Becton Dickinson & Co.	1	BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory software solution providing data management and workflow management functionality across locations where clinical diagnostic activities take place. Catalog Number: 444150

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021394862. Last updated year: 2026. Please use registration number 3021394862 when referencing this establishment in official correspondence.