This company has registrations in United States, Brazil, Australia — 3 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 | K241167 | BioSphere Putty; BioSphere MIS Putty | 2024-12-20 |
| US | K173424 | BioSphere Flex | 2018-09-12 |
| US | K173301 | BioSphere MIS Putty (BioSphere MIS) | 2018-01-19 |