This company has registrations in United States, Canada, Singapore, 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.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| US | K251653 | SPRY TMS Therapy System (0550) | 2026-02-20 |
| US | K233751 | Milieve (YPS-301BD) | 2024-06-03 |
| US | K234080 | MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S) | 2024-03-25 |