This company has registrations in United States, Brazil, Canada, Singapore, South Korea, Hong Kong, 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.
Business registration data from Israel Companies Registrar, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| US | K173581 | Gallant PTCA Dilatation Catheter | 2018-01-25 |
| US | K162434 | NC Gallant PTCA Catheter | 2017-01-19 |
| US | K150487 | X-Suit NIR Biliary Metallic Stent | 2016-02-12 |
| CA | 62809 | NIRFLEX PREMOUNTED STENT | Class IV |
| CA | 84540 | X-SUIT NIR BILIARY METALLIC STENT | Class III |
| CA | 86087 | PRESILLION PLUS COCR CORONARY STENT ON RX SYSTEM | Class IV |