Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9617472

FEI Number

3005737891

Entity Name

THERMO ELECTRON LED GmbH

City/State/Country

Langenselbold Hesse, DE

Establishment Address

Robert-Bosch-Strasse1, Langenselbold Hesse 63505, DE

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,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

K023465

PMA Number

N/A

All Registered Proprietary Names

Thermo Scientific Heracell 240i Incubator Thermo Scientific Heracell 150i Incubator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MQG	Accessory, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6120	2008-09-05

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
8010672	THERMO ELECTRON LED GmbH	OSTERODE Lower Saxony, DE
1523845	THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC	MARIETTA, OH, US

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0029-2020	CooperSurgical, Inc.	2	Embryology Heated Plate within the RI Witness, Model Numbers 6-70-807, 6-70-807-A, & 6-70-807-B - Product Usage: RI Witness uses Radio Frequency Identification (RFID) to detect and monitor all activity in the IVF laboratory. The system helps mitigate the risk of human error every time samples are moved from one dish or tube to another, and safeguards every step of the IVF cycle. While the heated plates comprise a heated composite surface with window for a light source. The heated plates comprise a heated composite surface with window for a light source and either sit on top of existing bench-tops or can be integrated to be flush fitted within workstations. Intended use: Provide a favorable temperature environment for the embryo during the IVF procedure.

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3009747883	Esco Medical Technologies, UAB	Ramuciai Kauno Apskritis, LT
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9617472. Last updated year: 2026. Please use registration number 9617472 when referencing this establishment in official correspondence.