This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel — 9 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 | K192195 | Sterile Dilator | 2019-09-26 |
| US | K182660 | GaltTWS | 2019-05-30 |
| US | K173287 | Elite HV Radial | 2017-12-21 |
| BR | 10350530194 | Introdutor Microslide | Class II |
| BR | 10350530195 | Kit de Introdutores Tearaway | Class II |
| BR | 10350530196 | Fio-guia Bentson | Class II |