DIXI Medical
FR-MF-000005237 · France · MARCHAUX-CHAUDEFONTAINE
DIXI Medical is registered in the European database on medical devices as a manufacturer, with 80 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 55 |
|---|---|
| Class I | 25 |
Most frequent device types declared: Connection cable, Cortical Electrode, Cortical electrode, Depth report device, Generator interface cable.
Among these devices, 26 are declared sterile, 1 reusable, 11 active, 2 with a measuring function.
Devices declared under this manufacturer
- Connection cable
- Cortical electrode (1x4)
- Cortical electrode (1x6)
- Cortical electrode (2x8)
- Depth report device
- Generator interface cable
- Implantation kit (Coagulation Electrode and Stop)
- Instrument guide
- Long screwdriver
- Microdeep Depth Electrode (15 contacts)
- Microdeep Depth Electrode (3x5 contacts)
- Microdeep Depth Electrode (5 contacts)
Showing 12 of 80 declared devices.
Catalogue references include 302657-000-INTL, ACS-714, CBL-08/180, CBL-08/300, CBL-15/300, CBL-18/120.
European nomenclature codes declared: N018099, N0101020101, N0101020102, N01800199.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | DIXI MEDICAL (FR) · FDA 3007636029 |
| Devices in EUDAMED | 80 |
| Country of registration | France |
Device-level evidence
| Devices with a numeric GTIN | 80 |
|---|---|
| Found in the U.S. device database | 57 |
| Share | 71.2 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | DIXI MEDICAL |
What it holds in Canada
| Licences on record | 7 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 6 |
| Class 4 devices | 1 |
| First licensed | 2005-01-05 |
Licence types: Device Family (6), Device Group Family (1).
Licensed under: STYLET HEMISPHERIQUE POUR NEUROCHIRURGIE STERE, VIS DE GUIDAGE POUR NEUROCHIRURGIE STEREOTAXIQ, ELECTRODE PROFONDE, CABLE DE CONNEXION, ELECTRODES CORTICALES, KIT D'IMPLANTATION.
North American profile: Both markets. DIXI Medical is registered in both the United States and Canada.