FDA Registration Active 🇳🇱 Netherlands

TECHNOMED EUROPE

Reg #: 9710376 · FEI: 3001450493 · Expires 2026
Products
6
Proprietary Names
69
Establishment Types
4
Classifications
6

Registration Details

Registration Name
TECHNOMED EUROPE
Registration Number
9710376
FEI Number
3001450493
Status
Active
Expiry Year
2026
Initial Importer
No
Address
Wiebachstraat 25a
City
Kerkrade Limburg
Country
NL

Regulatory Submissions

510(k) Number
K072016

Owner / Operator

Firm Name
Technomed Europe
Operator Number
9036062
Address
Wiebachstraat 25a
City
Kerkrade
State
Limburg
Postal Code
6466NG
Country
NL
Correspondent
Heather Pendlebury

US Agent

Business Name
Technomed USA, Inc.
Contact Name
Jennifer Maahs
Address
1626 Terrace Dr
City
Roseville
State
MN
ZIP
55113
Country
US
Phone
651 2880890

Products

Device Name Product Code
Electrode, Cutaneous GXY
Electrode, Needle GXZ
Electrode, Needle, Diagnostic Electromyograph IKT
Stimulator, Nerve ETN
Cable, Electrode IKD
Stimulator, Nerve, Peripheral, Electric KOI

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 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 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 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 Disposable Stimulation Probe Disposable Ball Tip Probe Disposable XL Pedicle Screw Probe Disposable Pedicle Screw Probe Disposable Adhesive Surface Electrode Disposable NCV Electrode kit Disposable Adhesive Surface Electrode, twisted Disposable Adhesive Surface Electrode, ground Disposable Adhesive Ground Electrodes Disposable Adhesive 4-Disk Electrodes TetraSens

Establishment Types

Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility