Neuromedex GmbH
DE-MF-000005867 · Germany · Hamburg
Neuromedex GmbH is registered in the European database on medical devices as a manufacturer, with 45 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 22 |
|---|---|
| Class IIb | 12 |
| Class I | 11 |
Among these devices, 45 are declared sterile, 12 implantable.
Devices declared under this manufacturer
- Hirnbiopsie Kanüle, navigierbar
- Hirnbiopsiekanüle
- Hirnbiopsiekanüle, navigierbar
- Kauterspitzen-Reiniger
- Mediloops® Gefäßschlinge
- Navigationsmarker-Kugel M3
- Navigationsmarker-Kugel Snap
- Sternum Verschluss-System
- Temporäre Myokardiale Elektrode (TME)
- VentrEX® EVD-System
Showing 12 of 45 declared devices.
Catalogue references include 01.2801, 01.2802, 01.2813, 01.2822, 449.F7, 449.F9.
European nomenclature codes declared: H010202010101, H900299, Z12011485, A010206, Z12050603, V0703.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Neuromedex GmbH (DE) · FDA 3009829742 |
| Devices in EUDAMED | 45 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 45 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: United States only. Neuromedex GmbH is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
1261GB448260326 | supplemented | 2027-04-12 |
10555GB450260803 | issued | 2031-08-02 |
10551GB450260311 | reissued | 2028-01-05 |