This company has registrations in United States, Brazil, Canada — 3 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 | K253198 | NanoKnife Generator (H78720300351US0) | 2026-03-24 |
| US | K252509 | AlphaVac Multipurpose Mechanical Aspiration System F1885 | 2025-11-24 |
| US | K253106 | AngioVac Cannula | 2025-10-24 |
| BR | 10324860030 | CATETER DE DRENAGEM ABSCESSION | Class II |
| BR | 80102512277 | Sistema de acesso RITA StarBurst | Class II |
| BR | 10324860079 | BOMBA DE INFUSÃO INTELLIFLOW RITA | Class II |
| CA | 19435 | CRYSTALINE CATAHETER CONNECTOR | Class II |
| CA | 19436 | HIGH PRESSURE CONNECTING LINE | Class II |
| CA | 20614 | PRO INFUSION CATHETER | Class II |