Technomed Europe
NL-MF-000000064 · Netherlands · Kerkrade
Technomed Europe is registered in the European database on medical devices as a manufacturer, with 727 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 727 |
|---|
Most frequent device types declared: 202453-000, 202461-000, 302296-000-039, 5888-00, 675.705S.
Among these devices, 441 are declared sterile.
Devices declared under this manufacturer
- Disposable Adhesive Surface Electrode
- Disposable Concentric Needle Electrode
- Disposable Concentric Probe
- Disposable EEG Cup Electrode, Silver-Silver Chloride (AgAgCl) coated
- Disposable EEG Cup+ Electrode Ag/AgCl coated
- Disposable Hypodermic Needle Electrode
- Disposable NCV Electrode Kit
- Disposable Stimulating Dissectors
- Disposable Stimulation clip
- Disposable Subdermal Needle Electrode
- Disposable Subdermal Needle Electrode, corkscrew
- Disposable Subdermal Needle Electrode, twisted
Showing 12 of 727 declared devices.
Catalogue references include 202453-000, 302296-000-039, 302315-000-039, 5888-00, TE/C53-438, TE/K50430-015.
European nomenclature codes declared: N010101, N01010299, N01010202, Z12101185, V9099, C010380.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | TECHNOMED EUROPE (NL) · FDA 9710376 |
| Devices in EUDAMED | 727 |
| Country of registration | Netherlands |
Device-level evidence
| Devices with a numeric GTIN | 727 |
|---|---|
| Found in the U.S. device database | 643 |
| Share | 88.4 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | TECHNOMED EUROPE |
What it holds in Canada
| Licences on record | 13 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 13 |
| First licensed | 2009-05-29 |
Licence types: Device Family (9), Device Group Family (4).
Licensed under: ADHESIVE ELECTRODES FOR EMG, EEG & EP, ELECTRODES FOR NEUROPHYSIOLOGICAL EXAMINATIONS, DISPOSABLE STIMULATING PROBES, EMG NEEDLE ELECTRODES, NEEDLE ELECTRODE EEG, EXTENSION CABLES.
North American profile: Both markets. Technomed Europe is registered in both the United States and Canada.