This company has registrations in United States, Brazil, Taiwan, 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 | K251442 | TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1) | 2025-10-02 |
| US | K211025 | Oral/Enteral Syringe with ENFit connector | 2021-06-30 |
| US | K210621 | Oral/Enteral Syringe | 2021-04-28 |
| BR | 80133959015 | Linha de Sangue Extracorpórea SAVA T400807 | Class II |
| BR | 80133959016 | Linha de Sangue Extracorpórea SAVA T400808 | Class II |
| BR | 80133959017 | Linha de Sangue Extracorpórea SAVA T400806 | Class II |