This company has registrations in United States, Brazil, South Korea, Australia, Hong Kong, Russia — 6 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 | K210313 | EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter | 2022-12-30 |
| US | K212626 | PathBuilder Transseptal Guiding Introducer | 2022-03-23 |
| US | K212625 | PathBuilder Transseptal Needle | 2022-03-23 |
| BR | 81667100081 | Cabo FORLNK | Class I |
| BR | 81667100034 | Conjunto de Tubos OptimAblate | Class II |
| BR | 81667100064 | Patch de referência de Impedância Columbus | Class I |