This company has registrations in United States, Canada, Israel — 3 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 | K241700 | Tenex 2nd Generation System | 2024-11-18 |
| US | K212556 | mi-eye 3 needlescope with cannula, mi-tablet 3 | 2021-09-15 |
| US | K162475 | mi-eye 2, mi-eye 2 monitor | 2016-09-16 |
| CA | 99830 | MI-EYE 2 CAMERA ENABLED PROBE | Class II |
| CA | 101160 | MI-PROBE | Class II |