This company has registrations in United States, Taiwan — 2 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 | K221452 | DiLumen C1, EZ1 and Tool Mount | 2023-02-10 |
| US | K211819 | DiLumen C2 and Tool Mount | 2021-10-22 |
| US | K210851 | DiLumen Endolumenal Interventional Platform (DiLumen) | 2021-04-21 |