Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8010707

FEI Number

7298

Entity Name

SIGMA LABORZENTRIFUGEN GMBH

City/State/Country

OSTERODE Lower Saxony, DE

Establishment Address

An der Unteren Soese 50, OSTERODE Lower Saxony 37520, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SIGMA LABORZENTRIFUGEN GMBH (Owner Number: 10037720)

Owner / Operator Contact Address

An der Unteren Soese 50, OSTERODE, DE-NI 37520, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

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	2011-08-10

Official Correspondent

MICHAEL SANDER

US Agent Details

Kristina Bales Business: Beckman Coulter Inc. Email: kristina.bales@beckman.com Phone: (317) 3150400

Related Public Records

Same Entity

SIGMA LABORZENTRIFUGEN GMBH

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010707. Last updated year: 2026. Please use registration number 8010707 when referencing this establishment in official correspondence.