This company has registrations in United States, Brazil, Canada, Taiwan — 4 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 | K251038 | Digital Radiographic Imaging Acquisition Software - DR (RiasDR) | 2025-08-06 |
| US | K223037 | Infrared Thermometer, Model: IR8807 | 2023-07-21 |
| US | K223044 | Digital Thermometer (Model QT001) | 2023-05-10 |
| BR | 81972600002 | FAMÍLIA ANALISADOR BIOQUIMICO AMAMEDICAL | Class II |
| BR | 81972600003 | ANALISADOR HEMATOLÓGICO AMAMEDICAL | Class II |
| BR | 81972600005 | ANALISADOR HEMOTOLÓGICO AUTO LOADER AMA-H6035 | Class II |