This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Israel — 7 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 | K253582 | Medical Imaging Calibration Feature (MICF) | 2026-04-01 |
| US | K250507 | Hypertension Notification Feature (HTNF) | 2025-09-11 |
| US | K250143 | Digital Prism Correction Feature (DPCF) | 2025-06-23 |
| BR | 80117581265 | Recurso de Notificação de Hipertensão | Class II |
| BR | 80117581018 | Recurso de Histórico de Fibrilação Atrial | Class II |
| BR | 80117581190 | Recurso de Notificações de Apneia do Sono | Class II |