This company has registrations in United States, Brazil, Canada, Taiwan, Hong Kong, Israel — 6 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.
Business registration data from SEC EDGAR, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| US | K243657 | ClearPoint System (Software Version 3.0) | 2025-01-24 |
| US | DEN240023 | SmartFlow Neuro Cannula | 2024-11-13 |
| US | K233703 | Bone Anchor (NGS-BA-01) | 2024-04-26 |
| BR | 80117581012 | IMRIS MR Neuro Drapes (Patient and Bore) | Class I |
| BR | 80117581013 | MR Neuro Drapes - Long | Class I |
| BR | 80117589065 | SmartTip MR Drill Kit | Class II |