Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8010471

FEI Number

5833

Entity Name

EPPENDORF SE

City/State/Country

HAMBURG, DE

Establishment Address

BARKHAUSENWEG 1, HAMBURG 22339, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Eppendorf SE (Owner Number: 8010471)

Owner / Operator Contact Address

175 Freshwater Blvd., Enfield, CT 06082, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Centrifuge 5702; Centrifuge 5702 R; Centrifuge 5702 RH Tips 1000 micro liter, non-conductive pipette tip with filter, 08176337001 LIAISON XL Disposable Tips (X0015 and X0055)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	Class 1	862.2050	2013-03-25
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2019-03-09

Official Correspondent

Denise Case

US Agent Details

Denise Case Business: Eppendorf North America Email: case.d@eppendorf.com Phone: (800) 6443405

Related Public Records

Same Entity

Eppendorf SE

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3005332796	Eppendorf Manufacturing Corporation	Enfield, CT, US
3015286853	Eppendorf Polymere GmbH	Oldenburg Schleswig-Holstein, DE
3011544811	Eppendorf Zentrifugen GmbH	Leipzig Saxony, DE

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.

Similar Registrations

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3004198394	BECKMAN COULTER, INC.	INDIANAPOLIS, IN, US
3033848228	JOAN LAB EQUIPMENT (ZHEJIANG) CO.,LTD.	Huzhou Zhejiang, CN
3004142400	GLOBUS MEDICAL, INC.	AUDUBON, PA, US
3017155466	KIT COMPANY	Phoenix, AZ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010471. Last updated year: 2026. Please use registration number 8010471 when referencing this establishment in official correspondence.