This company has registrations in United States — 1 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 | K151137 | X-VIEW, IMAGEN | 2016-06-07 |
| US | K150823 | EDLENi Intra-Oral Sensor | 2015-08-26 |
| US | K103290 | EDLEN IMAGING - GEMINI DUSB | 2011-09-19 |