This company has registrations in United States, Brazil, Saudi Arabia, Canada — 4 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 | K213467 | EVA NEXUS Ophthalmic Surgical System | 2022-06-14 |
| US | K190875 | EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector) | 2019-09-25 |
| US | K160591 | D.O.R.C. Disposable Cryo Probe | 2017-01-23 |
| BR | 80047309230 | Pack EVA NEXUS, TDC combinado (23 gauge, 25 gauge e 27 gauge) | Class II |
| BR | 80047309231 | Pack EVA NEXUS, TDC combinado (23 gauge, 25 gauge e 27 gauge) | Class II |
| BR | 80047309174 | Tubos descartáveis completos com filtro para troca de fluido de ar | Class II |
| SA | ME0000008532SFDAA00001 | Large Replacement Backflush Reservoir | — |
| SA | ME0000007906SFDAA00002 | Eckardt Backflush Handpiece With Luer Lock | — |
| CA | 8279 | VITREOUS SHAVER | Class II |
| CA | 9895 | CRYOPROBE | Class II |
| CA | 64501 | DISPOSABLE ECKARDT MEMBRANE PIC | Class II |