This company has registrations in United States, Brazil, Singapore, Australia, Israel, Russia — 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 | K170431 | CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT Syringe Dual Pack for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), Single Fascia and Ram Tip, Dual Fascia and Ram Tip | 2017-08-18 |
| US | K161471 | MR Syringe Dual Pack for Solaris Injectors | 2016-10-06 |
| US | K150902 | 330psi Extension Y-Line with Dual Check Valve | 2015-10-22 |
| BR | 10309090027 | ADAPTADOR FRONTAL PARA MÁQUINAS INJETORAS DE CONTROLE DE CONTRASTE COE | Class II |
| BR | 10309090025 | SERINGA PARA INJEÇÃO DE CONTRASTE COEUR | Class II |
| BR | 10309090026 | KIT PARA INJEÇÃO DE MEIO DE CONTRASTE COEUR | Class II |