This company has registrations in United States, Brazil, Taiwan, South Korea, Australia, Israel — 6 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 | K223010 | Portable X-ray System | 2023-01-17 |
| US | K222886 | Mercu 1717V | 2022-10-20 |
| US | K221714 | Flat Panel Detector | 2022-06-29 |
| BR | 80970159003 | Detector Digital de Raios-X | Class II |
| BR | 80348969005 | SISTEMA RADIOGRÁFICO DIGITAL INTRAORAL | Class II |
| BR | 80970150002 | DETECTOR DIGITAL DE RAIOS-X IRAY | Class II |