This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Israel, Russia — 8 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 | K231160 | Cardio Q50, Cardio Q70 | 2023-12-15 |
| US | K231150 | Cardio P1 | 2023-11-09 |
| US | K220535 | Cardio10 | 2022-11-15 |
| BR | 81961919005 | Scanner de ultrassom tipo sonda sem fio | Class II |
| BR | 80070219020 | MONITOR FETAL CARDIOTOCÓGRAFO FETALCARE | Class II |
| BR | 80070219021 | MEDIDOR DE SINAIS VITAIS | Class II |