This company has registrations in United States, Brazil, Singapore, Russia — 4 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 | K024007 | SUNDER CENTRAL VENOUS CATHETER KIT, MODELS SD-3L55F30J AND SD-3L70F30J | 2003-07-14 |
| US | K014140 | RENAX HEMODIALYSIS BLOOD TUBING SET; SUNDER HEMODIALYSIS BLOOD TUBING SET | 2002-11-18 |
| US | K003123 | RENAX A.V. FISTULA NEEDLE SETS | 2001-05-04 |
| BR | 80188519003 | ISOLADOR DE PRESSÃO DIALINE | Class II |
| BR | 80188510017 | CONECTORES | Class II |
| BR | 80188510020 | LINHA DE SANGUE ARTERIAL PARA HEMODIALISE | Class II |