This company has registrations in United States, Brazil, Canada, Taiwan, South Korea — 5 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 | K231534 | 5008X Hemodialysis System | 2024-02-02 |
| US | K141997 | CRIT-LINE IV SYSTEM | 2015-04-01 |
| US | K111639 | FRESENIUS 2008T HEMODIALYSIS MACHINE | 2011-10-21 |
| BR | 80133959024 | Reprocessadora de Filtro Dialisador Quality 1 | Class II |
| BR | 80133950158 | Poltrona para hemodiálise Saubern | Class I |
| BR | 80133950052 | DIALESTERIL NEONATAL | Class II |
| CA | 13931 | ON-LINE HDF FILTER | Class III |
| CA | 13953 | HEMOFLOW CAPILLARY DIALYZER | Class III |
| CA | 73158 | HAEMODIALYSIS SYSTEM 4008 H | Class III |