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
- [email protected]
- Phone
- 651 2880890
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2008-01-02 |
| Electrode, Needle | GXZ | Class 2 | Neurology | No | 2013-08-09 |
| Electrode, Needle, Diagnostic Electromyograph | IKT | Class 2 | Physical Medicine | No | 2013-08-09 |
| Stimulator, Nerve | ETN | Class 2 | Ear, Nose, Throat | No | 2011-11-28 |
| Cable, Electrode | IKD | Class 2 | Physical Medicine | No | 2001-11-15 |
| Stimulator, Nerve, Peripheral, Electric | KOI | Class 2 | Anesthesiology | No | 2020-04-24 |
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