This company has registrations in United States, Brazil, South Korea, Israel, Russia — 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 | K143476 | Digi-One | 2015-06-23 |
| US | K062578 | DIGI-LITE TCD DEVICE | 2006-09-18 |
| US | K974588 | INTRA-VIEW BILATERAL TRANSCRANIAL DOPPLER DEVICE, SMART-LITE PORTABLE BILATERAL TRANSCRANIAL DOPPLER DEVICE, COMPACT MOD | 1998-08-07 |
| BR | 10263619006 | EQUIPAMENTO DE ULTRASSONOGRAFIA DOPPLER TRANSCRANIANO DIGITAL - DIGI-O | Class II |
| BR | 10263619003 | EQUIPAMENTO PARA ULTRASONOGRAFIA DOPPLER TRANSCRANIANO DIGITAL DIGI-LI | Class II |