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 | K212719 | Micro Catheter and Guidewire System | 2022-04-11 |
| US | K210562 | HRSpheres Narrow-Size Embolic Microspheres | 2021-10-01 |
| US | K193653 | Hydrophilic Coating Guide Wire | 2020-08-26 |