Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9612389

FEI Number

3003255845

Entity Name

EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH

City/State/Country

BERLIN, DE

Establishment Address

GUBENER STR. 47,, FABRIKGEBAEUDE, BERLIN D-10243, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH (Owner Number: 9042702)

Owner / Operator Contact Address

GUBENER STR. 47,, FABRIKGEBAEUDE, BERLIN, DE-NOTA D-10243, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K192889

PMA Number

N/A

All Registered Proprietary Names

StimGuide waveguard net eego cognitrace neo monitor neo

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OBP	Transcranial Magnetic Stimulator	Neurology	Class 2	882.5805	2019-06-12
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2024-12-05
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2012-12-17
OMA	Amplitude-Integrated Electroencephalograph	Neurology	Class 2	882.1400	2020-02-20
ORT	Burst Suppression Detection Software For Electroencephalograph	Neurology	Class 2	882.1400	2020-02-20
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2020-02-20

Official Correspondent

Maarten van de Velde

US Agent Details

Dana Coggin Business: Quality & Regulatory Help, LLC Email: dana@qrahelp.com Phone: (715) 3605401

Related Public Records

Same Entity

EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K243700	Mag & More GmbH	Apollo TMS Therapy System	2025-09-04
K231926	Neuronetics, Inc.	NeuroStar Advanced Therapy System (All previously cleared models)	2024-03-22
K070612	Top-Rank Health Care Equipment Co., Ltd.	TOP-RANK ADHESIVE ELECTRODE	2007-05-07
K123915	Grass Technologies, an Astro-Med, Inc. Product Gro	DE48-PLUS	2013-04-24
K073532	Technomed Europe	DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES	2008-05-01

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2008	Bio-Logic Systems Corp	2	Bio-logic System Corp --Telescoping Camera Pole Assembly (part number 585-CYBPSM and 580-VIDPOL) and assemblies (580IPCART and 580 PNCART; Bio-Logic Systems Corporation, Mundelein, IL 60060; The Model 580-VIDPOL is used with the 580-PNCART that is wired for use with a Panasonic Camera. The pole is also a subassembly of the 585-CYBPSM with wires used in the 580-IPCART wired for the use with an Ipela Camera. Both carts are a component of the Ceegraph/Sleepscan Netlink with Video.

Similar Registrations

Registration Number	Establishment Name	Location
3018708317	MAGNUS MEDICAL INC.	Burlingame, CA, US
3039167582	NEUROMODULATORY DEVICES & APPLICATIONS (NMDA), INC	San Diego, CA, US
3007147067	NEXSTIM PLC	Helsinki Uusimaa, FI
3003144120	SPARTRONICS STRONGSVILLE, INC.	Strongsville, OH, US
8021774	THE MAGSTIM COMPANY LTD.	Carmarthenshire Wales, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9612389. Last updated year: 2026. Please use registration number 9612389 when referencing this establishment in official correspondence.