This company has registrations in United States, Brazil, Canada, 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 | K231169 | STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) | 2023-05-25 |
| US | K223015 | STERLINK FPS-15s Plus sterilizer with STERPACK plus cassette | 2023-05-09 |
| US | K223025 | Tyvek Roll with CI for STERLINK Sterilizer | 2023-05-09 |
| BR | 81046479001 | STERLINK FPS-15s Plus | Class II |