Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007701713

FEI Number

3007701713

Entity Name

EMS HANDELS GESELLSCHAFT M.B.H.

City/State/Country

Korneuburg Niederosterreich, AT

Establishment Address

Jochingergasse 1, Korneuburg Niederosterreich A-2100, AT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

EMS Handels Gesellschaft m.b.H. (Owner Number: 10055944)

Owner / Operator Contact Address

Jochingergasse 1, Korneuburg, AT-3 A-2100, AT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K171397

PMA Number

N/A

All Registered Proprietary Names

Amplifier Physiological Signal

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GWL	Amplifier, Physiological Signal	Neurology	Class 2	882.1835	2017-10-19
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2017-10-19

Official Correspondent

No official correspondent registered.

US Agent Details

Kristi Leigh Business: Smith Associates Imports Email: kleigh@fdaconsultants.com Phone: (410) 8149993

Related Public Records

Same Entity

EMS Handels Gesellschaft m.b.H.

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

View Entity Profile →

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
3038274470	BRAINMATTERZ, INC	McKinney, TX, US
3015614098	CGX, LLC	San Diego, CA, US
3020018	CADWELL INDUSTRIES, INC.	KENNEWICK, WA, US
3010762896	NEUROELECTRICS BARCELONA S.L.U.	Barcelona Catalonia, ES
3005713796	G.TEC MEDICAL ENGINEERING GMBH	SCHIEDLBERG Oberosterreich, AT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007701713. Last updated year: 2026. Please use registration number 3007701713 when referencing this establishment in official correspondence.