This company has registrations in United States, Brazil, South Korea — 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 | K162387 | U-IGNITE Bladeless Trocar | 2017-01-11 |
| US | K162648 | U-Blade Veress Needle | 2016-12-12 |
| BR | 80518270032 | Trocater Descartável SEKT | Class II |
| BR | 80518270033 | Agulha de Veress Descartável SEKT | Class II |