Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9710376

FEI Number

3001450493

Entity Name

TECHNOMED EUROPE

City/State/Country

Kerkrade Limburg, NL

Establishment Address

Wiebachstraat 25a, Kerkrade Limburg 6466 NG, NL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Technomed Europe (Owner Number: 9036062)

Owner / Operator Contact Address

Wiebachstraat 25a, Kerkrade, NL-LI 6466NG, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K050325

PMA Number

N/A

All Registered Proprietary Names

Reusable Ear Clip Electrode Disposable EEG Cup Electrode Ag/AgCl coated Reusable Ear clip Electrode Ag plated Reusable EEG Cup Electrode Ag plated Reusable Ear clip Electrode Au plated Reusable EEG Cup Electrode Au plated Disposable EEG XS Cup Electrode Ag/Agcl coated Disposable EEG Cup Electrode Reusable EEG Cup Electrode Reusable EEG Cup Electrode Ag/AgCl coated Reusable Ear clip Electrode Ag/AgCl coated Disposable EEG Cup+ Electrode Disposable EEG Cup+ Electrode Ag/AgCl coated Disposable EEG XS Cup Electrode Disposable Monopolar Needle Electrode, detachable, trocar tip Disposable Monopolar Needle Electrode, detachable, pencil tip Disposable Subdermal Needle Electrode Disposable Monopolar Needle Electrode, pre-wired, trocar tip Disposable Subdermal Needle Electrode, XS Disposable Subdermal Needle Electrode, Pt/Ir Disposable Subdermal Needle Electrode, hooked Disposable Monopolar Needle Electrode Disposable Subdermal Needle Electrode, curved Disposable Subdermal Needle Electrode, corkscrew Disposable Subdermal Needle Electrode, twisted Disposable Monopolar Needle Electrode, pre-wired, pencil tip Disposable Subdermal Needle Electrode, parallel Disposable XS Subdermal Needle Electrode Premium Neuro Single Kit Disposable Subdermal Needle Electrode, corkscrew, twisted Disposable Subdermal Needle Electrode, corkscrew, twisted Disposable Subdermal Needle Electrode, corkscrew Disposable Stimulating Curved Needle Disposable Surgical Instrument Disposable Stimulating Ring Dissector Disposable Stimulating Dissectors Disposable Stimulating Elevators Lantern Laryngeal Electrode Disposable Concentric Needle Electrode Pt/Ir electrode, Gold plated needle Reusable Concentric Needle Electrode Disposable Concentric Needle Electrode Reusable Subdermal Needle Electrode Disposable Subdermal Needle Electrode, Pt/Ir Disposable Hypodermic Needle Electrode Reusable Shielded Cable Reusable Unshielded Cable Disposable Stimulation Clip Stimulation Clip Reusable Unshielded Cable for detachable monopolar EMG needle electrode Reusable Shielded Cable for detachable monopolar EMG needle electrode Reusable Shielded Cable for concentric + single fiber EMG needle electrode Premium Neuro Single Kit Extension cable DIN male to female Standard Neuro Single Kit Disposable Stimulation Probe Disposable Bipolar Probe, twisted Disposable Triple Hooked Probe Disposable Monopolar Probe Disposable Concentric Probe Disposable Stimulation Probe Disposable Concentric Probe, twisted Disposable Double Hooked Probe Disposable Bipolar Probe Disposable Stimulation Probe Disposable XL Monopolar Probe Disposable Stimulation Probe Disposable Monopolar Probe

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2008-01-02
GXZ	Electrode, Needle	Neurology	Class 2	882.1350	2013-08-09
IKT	Electrode, Needle, Diagnostic Electromyograph	Physical Medicine	Class 2	890.1385	2013-08-09
GXZ	Electrode, Needle	Neurology	Class 2	882.1350	2024-12-17
IKT	Electrode, Needle, Diagnostic Electromyograph	Physical Medicine	Class 2	890.1385	2024-12-17
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2011-11-28
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2013-01-03
IKT	Electrode, Needle, Diagnostic Electromyograph	Physical Medicine	Class 2	890.1385	2026-03-17
GXZ	Electrode, Needle	Neurology	Class 2	882.1350	2026-03-17
IKT	Electrode, Needle, Diagnostic Electromyograph	Physical Medicine	Class 2	890.1385	2008-01-02
GXZ	Electrode, Needle	Neurology	Class 2	882.1350	2008-01-02
IKT	Electrode, Needle, Diagnostic Electromyograph	Physical Medicine	Class 2	890.1385	2008-01-02
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2001-11-15
GXZ	Electrode, Needle	Neurology	Class 2	882.1350	2008-01-02

Official Correspondent

Heather Pendlebury

US Agent Details

Jennifer Maahs Business: Technomed USA, Inc. Email: orderustechnomed@welcony.com Phone: (651) 2880890

Related Public Records

Same Entity

Technomed Europe

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007389997	Technomed USA, Inc.	Roseville, MN, US
3008892509	TECHNOMED ASIA, PT.	Bandung Jawa Barat, ID

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K073532	Technomed Europe	DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES	2008-05-01
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
K260363	Ceribell, Inc.	Ceribell Brain Monitor Headband	2026-04-03
K091762	Covidien	DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE	2009-12-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0023-2020	Stryker Instruments Div. of Stryker Corporation	2	C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.
Z-0024-2020	Stryker Instruments Div. of Stryker Corporation	2	C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9710376. Last updated year: 2026. Please use registration number 9710376 when referencing this establishment in official correspondence.