This company has registrations in United States, Brazil, Saudi Arabia, Canada — 4 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 | K261335 | VitalFlow Set with Balance Biosurface | 2026-07-31 |
| US | K261866 | Concerto Versa Detachable Coil | 2026-06-24 |
| US | K253530 | Trexon Monofilament Synthetic Absorbable Suture | 2026-05-28 |
| BR | 10349009019 | Sistema de Medição de Fluxo Sanguíneo Bio-Probe® | Class II |
| BR | 10349000952 | Cateter Guia Aórtico Abdominal Heli-FX | Class II |
| BR | 10349009014 | Introdutor de Cateter Descartável | Class II |
| SA | ME0000003921SFDAA00015 | Duran AnCore | — |
| SA | ME0000003921SFDAA00016 | Valve Handle | — |
| CA | 265 | MUSTANG STEERABLE GUIDWIRE | Class II |
| CA | 266 | SHERPA GUIDING CATHETER | Class II |
| CA | 283 | ASCENT GUIDING CATHETER | Class II |