Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8010672

FEI Number

3008237786

Entity Name

THERMO ELECTRON LED GmbH

City/State/Country

OSTERODE Lower Saxony, DE

Establishment Address

AM KALKBERG, OSTERODE Lower Saxony 37520, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

THERMO FISHER SCIENTIFIC INC. (Owner Number: 2182773)

Owner / Operator Contact Address

168 Third Avenue, --, Waltham, MA 02451, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Thermo Scientific Sorvall BP 8 Heavy Duty (75007684) Thermo Scientific Sorvall Lynx 6000 (75006590) Thermo Scientific Cryofuge 16 Heavy Duty (75007678) Thermo Scientific Cryofuge 8 (75007671, 75007672) Thermo Scientific Sorvall RC 4 (75004473, 75004477, 75004481) Thermo Scientific Sorvall Lynx 4000 (75006580) Thermo Scientific Cryofuge 16 Heavy Duty Water Cooled (75007677) Thermo Scientific Cryofuge 8 (75008603) Thermo Scientific Cryofuge 5500i (75004475, 75004479) Thermo Scientific Cryofuge 8 (75008600) Thermo Scientific Sorvall BP 8 Heavy Duty Water Cooled (75007662) Thermo Scientific Cryofuge 16 (75007673, 75007674) Thermo Scientific Sorvall BP 8 (75007681 and 75007689) Thermo Scientific Sorvall BP 16 Heavy Duty (75007688) Thermo Scientific Sorvall BP 16 (75007683 and 75007695) Thermo Scientific Sorvall BP 16 Heavy Duty (75007682) Thermo Scientific Sorvall BP 16 Heavy Duty Water Cooled (75007661) Thermo Scientific Cryofuge 16 Heavy Duty (75008618) Thermo Scientific Cryofuge 16 (75008610) Thermo Scientific Cryofuge 16 (75008615)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KSO	Centrifuge, Blood-Bank For In Vitro Diagnostic Use	Hematology	Class 1	864.9275	1996-02-14

Official Correspondent

No official correspondent registered.

US Agent Details

MARILYN BARRY Business: THERMO FISHER SCIENTIFIC Email: marilyn.barry@thermofisher.com Phone: (828) 6584400

Related Public Records

Same Entity

THERMO FISHER SCIENTIFIC 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
3003809634	Thermo Finnigan LLC	San Jose, CA, US
9610942	THERMO FISHER SCIENTIFIC OY	VANTAA Uusimaa, FI
1036832	THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC	ASHEVILLE, NC, US
1523845	THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC	MARIETTA, OH, US
9617472	THERMO ELECTRON LED GmbH	Langenselbold Hesse, DE

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3005990076	ANDREAS HETTICH GMBH	TUTTLINGEN Baden-Wurttemberg, DE
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010672. Last updated year: 2026. Please use registration number 8010672 when referencing this establishment in official correspondence.