This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 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 | K253327 | HANAROSTENT Esophagus Upper (CCC) | 2025-10-30 |
| US | K213251 | HANAROSTENT Esophagus Asymmetric (CCC) | 2021-11-18 |
| US | K201160 | HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN) | 2021-07-23 |