This company has registrations in United States, Canada, Taiwan — 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 | K150144 | VisuCon-F Low Fibrinogen Control Plasma | 2016-03-06 |
| US | K110432 | VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABN | 2011-10-20 |
| US | K091284 | VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORMAL AND ABNORMAL CONTROL PLASMA | 2009-10-28 |
| CA | 79913 | VISUCAL-F FROZEN CALIBRATOR PLASMA | Class II |
| CA | 80569 | VISUCON-F FROZEN NORMAL CONTROL PLASMA | Class II |
| CA | 80570 | VISUCON-F FROZEN ABNORMAL CONTROL PLASMA | Class II |