This company has registrations in United States, Brazil, Canada, Taiwan, South Korea, Australia, Israel, Russia — 8 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 | K212207 | Sterile Hypodermic Syringe for Single Use | 2023-03-23 |
| US | K212920 | Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for Single Use,Sterile Auto-Disable Syringe with Needle for Single Use | 2022-03-11 |
| US | K170861 | Premier | 2017-08-04 |
| BR | 10369460012 | AGULHA PARA COLETA DE SANGUE A VACUO | Class II |
| BR | 10369460012 | AGULHA PARA COLETA DE SANGUE A VACUO | Class II |
| BR | 80671380004 | Seringas Injetora de Contraste - ALLPRO | Class II |