This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 10 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 | K214057 | STATIM 6000B Vacuum Autoclave | 2022-03-31 |
| US | K210326 | Bravo G4 Chamber Autoclave | 2021-07-01 |
| US | K192910 | STATClave G4 Chamber Autoclave | 2020-06-19 |
| BR | 10302860018 | AUTOCLAVE STATIM SCICAN | Class II |
| BR | 10302860259 | AUTOCLAVE STATIM SCICAN | Class II |
| SA | ME0000000512SFDAA00001 | HIP™ Ultra Cleaning Solution with Instrument Protection | — |
| SA | ME0000000512SFDAA00002 | HIP™ Hydrim® Cleaning Solution with Instrument Protection | — |
| CA | 6965 | SCICAN RESECTOSCOPE | Class II |
| CA | 6974 | SCICAN ARTHROSCOPE | Class II |
| CA | 6975 | SCICAN URETHROSCOPE | Class II |