This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, South Korea — 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 | DEN230076 | Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP7460 (HEM-7371T1-AZ)); Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP5460 (HEM-7372T1-AZAZ)) | 2024-10-08 |
| US | K202228 | Omron Model BP7900 Blood Pressure Monitor + EKG | 2021-04-01 |
| US | K183215 | Focus TENS Therapy, Model PM710-M/-L | 2019-09-07 |
| BR | 81952079016 | Monitor de Pressão Arterial de Braço | Class II |
| BR | 81952079017 | Monitor de Pressão Arterial de Braço | Class II |
| BR | 81952079003 | MONITOR DE PRESSÃO ARTERIAL DE BRAÇO AUTOMÁTICO | Class II |
| SA | ME0000005433SFDAA00021 | AC Adapter | — |
| CA | 17690 | PULSE MASSAGER | Class II |
| CA | 17700 | VIBRATING MASSAGER | Class II |
| CA | 17705 | GENTLE TOUCH INSTANT EAR THERMOMETER | Class II |