This company has registrations in United States, Brazil, Saudi Arabia, Canada, Australia — 5 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 Corporations Canada, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| US | K242930 | Natus BrainWatch System | 2024-11-19 |
| US | K233649 | ALGO Pro Newborn Hearing Screener (ALGO Pro) | 2024-03-08 |
| US | K203500 | RetCam Envision | 2021-04-13 |
| BR | 80102512057 | SISTEMA AMPLIFICADOR EEG | Class II |
| BR | 80102512138 | Sistema XactTrace de Uso Único | Class II |
| BR | 80102512139 | Sistema XactTrace Reutilizável | Class II |
| SA | ME0000006691SFDAA00002 | RetCam Envision Lens | — |
| SA | ME0000006691SFDAA00001 | RetCam Envision System | — |
| CA | 500 | CEREBRAL FUNCTION MONITOR CFM 6000 | Class III |
| CA | 2069 | ISOTRON 220 ISOTRON AND 1000 PLUS POWERED MUSCLE STIMULATOR | Class II |
| CA | 2070 | ISOTRON II, ISOTRON III, ISOTRON IV 2 CHANNEL ELECTRO MUSCLE STIMULATOR | Class II |