This company has registrations in United States, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel — 8 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 | K242752 | MRidium 3870 MRI Infusion Pump System (3870) | 2025-05-28 |
| US | K180903 | 3880 MRI Patient Monitoring System | 2019-03-29 |
| US | K182900 | 3880 MRI Patient Monitoring System | 2018-12-14 |