This company has registrations in United States, Brazil, Canada — 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.
Business registration data from SEC EDGAR, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| US | K210575 | HDF Assist Mudule, HDF Infusion Set and Substitution Filter | 2022-05-13 |
| US | K161304 | EndoPur Filter | 2017-03-02 |
| US | K161467 | HydraGuard 10 UltraFilter | 2016-12-22 |
| BR | 80133959022 | EndoPur | Class II |
| BR | 80133959023 | SSUmini | Class II |
| CA | 75348 | OLPUR MD HEMODIAFILTER | Class III |