This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 10 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 | K252424 | Anti-HCV Next | 2026-04-28 |
| US | K243500 | ARCHITECT iGentamicin | 2025-07-09 |
| US | K243168 | Alinity i Rubella IgG | 2025-06-20 |
| BR | 10055310843 | PHOSPHORUS / FÓSFORO | Class II |
| BR | 10055310845 | GLUCOSE / GLICOSE | Class II |
| BR | 10055310939 | ICT SAMPLE DILUENT / ICT DILUENTE DE AMOSTRA | Class I |
| SA | ME0000002989SFDAA00176 | flexitainer | — |
| CA | 687 | BIODIVYSIO DIVYSIO PC STENT (UNMOUNTED STENT) | Class IV |
| CA | 71894 | EMBOSHIELD RAPID EXCHANGE & EMBOLIC PROTECTION SYSTEM | Class IV |
| CA | 688 | BIODIVYSIO CORONARY STENT SYSTEM | Class IV |