This company has registrations in United States, Brazil, Canada, South Korea, Australia, Hong Kong, Russia — 7 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 | K260351 | Numen Helia Coil Embolization System; NumenFR Detachment System | 2026-05-20 |
| US | K242154 | Numen Coil Embolization System; NumenFR Detachment System | 2024-09-30 |
| US | K232955 | Numen Coil Embolization System; NumenFR Detachment System | 2024-01-10 |