This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, 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 | K142567 | RETeval Visual Electrodiagnostic Device | 2015-05-19 |
| US | K914163 | SCOPTOPIC SENSITIVITY TEST-1[SST-1] | 1991-10-25 |
| US | K913962 | ANOMALOSCOPE QUADRANT TEST-6 | 1991-10-23 |
| BR | 81346509001 | RETeval Sensor Strips | Class II |
| CA | 66198 | UTAS-E3000MF VISUAL ELECTRODIAGNOSTIC TEST SYSTEM | Class II |
| CA | 95162 | RETEVAL-DR | Class II |