This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel — 8 overseas markets. The China NMPA lookup is still pending.
Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.
Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| US | K202087 | DIXI Medical Microdeep Micro-Macro Depth Electrodes | 2021-11-18 |
| US | K201931 | Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids) | 2021-10-02 |
| US | K170959 | DIXI Medical Microdeep Depth Electrode | 2017-11-24 |
| BR | 80299570017 | KIT INSTRUMENTAL PARA IMPLANTAÇÃO DE ELETRODOS | Class II |
| BR | 80299579002 | Cabo da interface do gerador | Class II |
| CA | 66976 | FORET POUR NEUROCHIRURGIE STEREOTAXIQUE | Class II |
| CA | 66977 | ACCESSOIRES POUR NEUROCHIRUGIE STEREOTAXIQUE TUBE DE GUIDAGE | Class II |
| CA | 68380 | ELECTRODE EPIDURALE | Class IV |