This company has registrations in United States, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel — 8 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 | K180970 | Disposable guides KDNG00 | 2018-07-10 |
| US | K171040 | Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range | 2017-07-31 |
| US | K170521 | TRINITY/3D PROSTATE SUITE | 2017-05-30 |
| CA | 93415 | UROSTATION 3D PROSTATE SUITE | Class II |
| CA | 98024 | MR DRAW | Class II |