This company has registrations in United States, Brazil, Canada — 3 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.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| US | K250738 | YSIO X.pree | 2025-07-31 |
| US | K250660 | LUMINOS Q.namix T; LUMINOS Q.namix R | 2025-07-14 |
| US | K233543 | YSIO X.pree | 2024-05-21 |
| BR | 10345160873 | PROLACTIN IMMULITE 2000 | Class II |
| BR | 10345160777 | RAPID TSH IMMULITE 2000 | Class II |
| BR | 10345160880 | ACTH CONTROL MODULE IMMULITE | Class II |
| CA | 12672 | TOSRAD UPH SYSTEM | Class III |
| CA | 12679 | TOSRAD CH SYSTEM | Class III |
| CA | 17345 | NUCLEAR MEDICINE CAMERA SYSTEM | Class II |