This company has registrations in United States, Canada, Taiwan, Singapore, Australia, Hong Kong, 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 | K240700 | HomeSleepTest (HST, HST REM+) | 2024-12-08 |
| US | K231104 | ABPMpro | 2023-11-27 |
| US | K212325 | EEG-acp | 2022-06-15 |
| CA | 75448 | SOMNOSCREEN | Class II |
| CA | 84108 | SOMNOWATCH PLUS | Class II |