This company has registrations in European Union, United States, Brazil, Canada, Taiwan, Singapore, 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 |
|---|---|---|---|
| EU | 00817980020092 | — | Class IIa |
| EU | 00817980020047 | — | Class IIa |
| EU | 00817980020184 | — | Class IIa |
| EU | 00817980020191 | Ambulatory Electrocardiograph | Class IIa |
| US | K111180 | VASOMEDICAL-BIOX 12- CHANNEL AMBULATORY ECG HOLTER RECORDER MODEL 1304, VASOMEDICAL-BIOX 3- CHANNEL MINIATURE AMBULATORY | 2011-06-28 |
| US | K111096 | VASOMEDICAL-BIOX COMBINED 12 CHANNEL AMBULATORY ECG AND BLOOD PRESSURE RECORDER MODEL 2302, VASOMEDICAL-BIOX AMBULATORY | 2011-06-24 |
| US | K092785 | COMBINED VASOMEDICAL-BIOX AMBULATORY ECG & BLOOD PRESSURE RECORDER & ANALYSIS SOFTWARE, 2301 | 2010-04-02 |
| BR | 80117580274 | VASOMEDICAL-BIOX MONITOR DE PRESSÃO ARTERIAL AMBULATORIAL | Class II |
| BR | 80117580275 | GRAVADORES DE HOLTER DE ECG VASOMEDICAL-BIOX | Class II |
| CA | 21738 | ENHANCED EXTERNAL COUNTERPULSATION (EECP) | Class II |
| CA | 60902 | EECP THERAPY MODEL TS3 SYSTEM | Class II |
| CA | 64215 | EECP THERAPY SYSTEM MODEL TS4 | Class II |