This company has registrations in United States, Brazil, Canada, Taiwan, Australia, Israel — 6 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 | K071255 | ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A | 2007-09-07 |
| US | K050367 | BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6 | 2006-05-24 |
| US | K050365 | BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202 | 2005-12-27 |
| BR | 80015490136 | ADP | Class II |
| BR | 80015490132 | Epinephrine | Class II |
| BR | 80015490133 | Collagen | Class II |
| CA | 73884 | ZYMUTEST FREE PROTEIN S | Class II |
| CA | 74231 | HEMOCLOT THROMBIN TIME (TT) | Class II |
| CA | 74751 | HEMOCLOT QUANTI V-L | Class II |