Data / Medical devices / Netherlands / Technomed Europe

Technomed Europe: FDA-registered device maker in Kerkrade Limburg, Netherlands, 12 510(k) clearances

Name: Technomed Europe FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Technomed Europe is registered with the FDA (registration 9710376) in Kerkrade Limburg, Netherlands. It lists 6 device types. The FDA files 12 510(k) clearances under its listings, the newest dated May 7, 2026. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 9710376
FEI number: 3001450493
Address: Wiebachstraat 25a, Kerkrade Limburg, Netherlands, 6466 NG
Owner or operator: Technomed Europe (9036062)
Roles: Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer
First device listed: November 15, 2001
Registered through: 2026
Brand names listed: Disposable Adhesive 4-Disk Electrodes, Disposable Adhesive Ground Electrodes, Disposable Adhesive Surface Electrode, Disposable Adhesive Surface Electrode, ground, Disposable Adhesive Surface Electrode, twisted, Disposable Bipolar Probe, Disposable Concentric Needle Electrode, Disposable Concentric Needle Electrode Pt/Ir electrode, Gold plated needle and more

Devices it lists

Device	Product code	Class	Role	Source
Cable, Electrode	IKD	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Electrode, Cutaneous	GXY	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Electrode, Needle	GXZ	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Electrode, Needle, Diagnostic Electromyograph	IKT	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Stimulator, Nerve	ETN	2	Manufacturer	accessdata.fda.gov
Stimulator, Nerve, Peripheral, Electric	KOI	2	Contract manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 7, 2026	K254183	MR Conditional Cup Electrodes	GXY	Substantially Equivalent	Technomed Europe	accessdata.fda.gov
March 15, 2026	K253581	Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable Concentric Needle Electrode 0.40x25mm Yellow (TE/B50700-002); Disposable Concentric Needle Electrode 0.30x30mm Pink (TE/B50700-006); Disposable Concentric Needle Electrode 0.45x37mm Green (TE/B50700-003); Disposable Concentric Needle Electrode 0.45x50mm Blue (TE/B50700-004); Disposable Concentric Needle Electrode 0.60x75mm Violet (TE/B50700-005)	IKT	Substantially Equivalent	Technomed Europe	accessdata.fda.gov
December 11, 2024	K241045	Disposable Subdermal Needle Electrode, Corkscrew	GXZ	Substantially Equivalent	Technomed Europe	accessdata.fda.gov
July 19, 2013	K130136	DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES,	GXZ	Substantially Equivalent	Technomed Europe	accessdata.fda.gov
August 28, 2012	K121257	LARYNGEAL ELECTRODE	ETN	Substantially Equivalent	Technomed Europe	accessdata.fda.gov
May 26, 2011	K110422	SURGICAL STIMULATORS	ETN	Substantially Equivalent	Technomed Europe	accessdata.fda.gov
May 1, 2008	K073532	DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES	GXY	Substantially Equivalent	Technomed Europe	accessdata.fda.gov
October 19, 2007	K072016	CUP ELECTRODES, GOLD, REUSABLE, SILVER, REUSABLE; CUP ELECTRODES SILVER/SILVER CHLORIDE REUSABLE	GXY	Substantially Equivalent	Technomed Europe	accessdata.fda.gov
August 21, 2007	K063729	DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00	GXZ	Substantially Equivalent	Technomed Europe	accessdata.fda.gov
February 16, 2007	K062437	DISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE VERSION AND PRIVATE LABELED	IKT	Substantially Equivalent	Technomed Europe	accessdata.fda.gov
May 5, 2005	K050325	DISPOSABLE CONCENTRIC PROBE, DISPOSABLE BIPOLAR PROBE, DISPOSABLE MONOPOLAR PROBE	GXZ	Substantially Equivalent	Technomed Europe	accessdata.fda.gov
May 27, 1999	K990015	ELECTRODE NEEDLES	IKT	Substantially Equivalent	Technomed Europe	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
July 25, 2024	95188	Class II	Ongoing	NEUROSIGN Disposable Stimulating Dissector, REF 5888-00	Product has have presence of brown discoloration or substance on the hinge area of the device	accessdata.fda.gov
August 9, 2022	90733	Class II	Terminated	Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile.	Burns of varying degrees can occur to patients with electrodes left in while in the MRI scanner as a result of inadequate safety information in the IFU.	accessdata.fda.gov
December 8, 2021	89126	Class II	Terminated	Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C, and TE/S50715-001.	There is a high risk of the blue hub detaching from the corkscrew needle, resulting the the needle remaining in the patient's scalp.	accessdata.fda.gov

Compare with other makers

Updated May 7, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.