This company has registrations in United States, Brazil, Saudi Arabia — 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 | K233395 | Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S) | 2024-01-03 |
| US | K230732 | Eagle S/Saevo Slim/D700 Slim | 2023-04-11 |
| US | K223816 | Dental CT Scanner AXR | 2023-04-07 |
| BR | 10101130056 | INSTRUMENTO DE MAO ODONTOLOGICO DE BAIXA ROTACAO | Class II |
| BR | 10101130055 | INSTRUMENTO DE MAO ODONTOLOGICO DE ALTA ROTACAO | Class II |
| BR | 10101139029 | Sistema Radiográfico Digital Intraoral | Class II |
| SA | ME0000000285SFDAA00001 | Water Unit | — |
| SA | ME0000013798SFDAA00007 | Dental Chair | — |