This company has registrations in United States, Brazil, Saudi Arabia, Canada — 4 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 | K223317 | Alkaline Phosphatase2 | 2023-07-21 |
| US | K223324 | Total Bilirubin2 | 2022-12-29 |
| US | K203597 | Cholesterol2 | 2022-06-30 |
| BR | 10055310998 | ARCHITECT PROLACTIN REAGENTS | Class II |
| BR | 10055311012 | ARCHITECT PROGESTERONE REAGENTS | Class II |
| BR | 80146502246 | Alinity i Cyclosporine Whole Blood Precipitation Reagent Kit | 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 |