This company has registrations in United States, Brazil, South Korea, Australia, Israel — 5 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 SEC EDGAR, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| US | K253096 | Chartis Precision Catheter | 2026-02-13 |
| US | K222340 | Chartis Precision Catheter | 2022-12-01 |
| US | K212494 | Lung Image Analysis | 2021-09-02 |
| BR | 80159019004 | CONSOLE DO SISTEMA DE AVALIAÇÃO PULMONAR CHARTIS | Class II |
| BR | 80159019009 | CATETER INTRODUTOR ENDOBRONQUIAL ZEPHYR | Class II |
| BR | 80159019001 | CATETER DO SISTEMA DE AVALIAÇÃO PULMONAR CHARTIS | Class II |