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 | K254183 | MR Conditional Cup Electrodes | 2026-05-07 |
| US | K253581 | Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable Concentric Needle Electrode 0.40x25mm Yellow (TE/B50700-002); Disposable Concentric Needle Electrode 0.30x30mm Pink (TE/B50700-006); Disposable Concentric Needle Electrode 0.45x37mm Green (TE/B50700-003); Disposable Concentric Needle Electrode 0.45x50mm Blue (TE/B50700-004); Disposable Concentric Needle Electrode 0.60x75mm Violet (TE/B50700-005) | 2026-03-15 |
| US | K241045 | Disposable Subdermal Needle Electrode, Corkscrew | 2024-12-11 |
| BR | 80969860043 | Sondas de Monitorização Technomed | Class II |
| BR | 80145902000 | CABOS DE INTERFACE | Class I |
| BR | 80517199012 | SafeSign | Class II |
| CA | 79854 | RF INJECTION NEEDLES | Class II |
| CA | 79857 | NASOPHARYNGEAL ELECTRODE FOR EEG | Class II |