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 | K253746 | Enroute 0.014'' Transcarotid Guidewire | 2026-03-19 |
| US | K242824 | PTFE Guidewire | 2024-12-06 |
| US | K221575 | Pre-Formed Blue | 2022-10-07 |
| BR | 10341350486 | FIO GUIA STARTER | Class II |
| BR | 10341350737 | FIO GUIA UROLÓGICO REVESTIDO EM PTFE | Class II |
| BR | 10341350515 | ZIPWIRE FIO GUIA HIDROFILICO | Class II |
| CA | 9411 | FLU VEN, IV SET | Class II |
| CA | 104751 | VISIONWIRE | Class II |