This company has registrations in European Union, Brazil, Israel — 3 overseas markets. EU UDI-DI records ≥19, the first 300 verified individually. 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 |
|---|---|---|---|
| EU | 06974247100073 | TABLETOP PULSE OXIMETER | Class IIb |
| EU | 06974247100035 | Vital Signs Monitor | Class IIb |
| EU | 06974247100059 | Vital Signs Monitor | Class IIb |
| EU | 06974247100080 | Patient monitor | Class IIb |
| BR | 80070219025 | OXÍMETRO DE PULSO DE MESA - MD | Class II |
| BR | 80070219017 | OXÍMETRO DE PULSO PORTÁTIL - MD | Class II |
| BR | 80540449008 | OXÍMETRO DE PULSO/ DEDO | Class II |