This company has registrations in United States, Brazil, Saudi Arabia, Taiwan, Australia, Israel, Russia — 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 | K261129 | OrthoFit | 2026-07-02 |
| US | K250566 | EsCem RMGI | 2025-06-20 |
| US | K250317 | EsFlow PLUS | 2025-05-30 |
| BR | 82555479009 | EsTemp C&B | Class II |
| BR | 82555479001 | EsCom 250 | Class II |
| BR | 82555479002 | EsCem | Class II |
| SA | ME0000006329SFDAA00009 | CALCIOPEX | — |
| SA | ME0000006329SFDAA00008 | CHELINE | — |