FDA Registration
Active
🇫🇷 France
DIXI MEDICAL
Reg #: 3007636029
·
FEI: 3007636029
·
Expires 2026
Products
4
Proprietary Names
22
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- DIXI MEDICAL
- Registration Number
- 3007636029
- FEI Number
- 3007636029
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2A ROUTE DE POULIGNEY CHAUDEFONTAINE
- City
- MARCHAUX-CHAUDEFONTAINE Doubs
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K170959
Owner / Operator
- Firm Name
- DIXI Medical
- Operator Number
- 10056327
- Address
- 2A ROUTE DE POULIGNEY CHAUDEFONTAINE
- City
- MARCHAUX-CHAUDEFONTAINE
- State
- Doubs
- Postal Code
- 25640
- Country
- FR
- Correspondent
- Lucie PETEGNIEF
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Depth | GZL | Class 2 | Neurology | No | 2017-11-29 |
| Cable, Electrode | IKD | Class 2 | Physical Medicine | No | 2021-12-09 |
| Instrument, Surgical, Non-Powered | HAO | Class 1 | Neurology | No | 2021-12-09 |
| Electrode, Cortical | GYC | Class 2 | Neurology | No | 2021-12-08 |
Proprietary Names
DIXI Medical Wrench
DIXI Medical Short Screwdriver
DIXI Medical Bone Starter
DIXI Medical Drill and Stop
DIXI Medical Anchor Bolt
DIXI Medical Coagulation Electrode and Stop
DIXI Medical Long Screwdriver
DIXI Medical Extension Cable
DIXI Medical Marking Rod
DIXI Medical Stylet
DIXI Medical Instrument Guide
DIXI Medical Cap for Anchor Bolt
DIXI Medical Depth Report Device
DIXI Medical Sliding Ruler
DIXI Medical Adapter
DIXI Medical Flat Screwdriver
DIXI Medical Microdeep Depth Electrode
DIXI Medical Connection Cable
DIXI Medical Microdeep® Micro-Macro Depth Electrode
DIXI Medical Stop
DIXI Medical Wire Guide
DIXI Medical Intraoperative Subdural Electrodes (Strips and Grids)
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device