This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Israel — 7 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 | K192348 | SICAT Implant V2.0 | 2019-12-04 |
| US | K180262 | SICAT Endo | 2018-03-12 |
| US | K153291 | SICAT OPTISLEEP | 2016-03-31 |
| BR | 80745400036 | SICAT IMPLANT | Class II |
| CA | 74518 | GALILEOS IMPLANT | Class II |