This company has registrations in United States, Brazil — 2 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 | K260394 | Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR) | 2026-06-24 |
| US | K222677 | Intermittent nelaton catheter for single use | 2023-04-05 |
| US | K200134 | Jimushi Sterile Urethral Catheter for single use | 2020-06-01 |
| BR | 10188530089 | CATETER URETRAL INTERMITENTE PRONTO PARA USO PVC (SEM BOLSA COLETORA) | Class I |
| BR | 10188530090 | CATETER URETRAL INTERMITENTE PRONTO PARA USO TPU (SEM BOLSA COLETORA) | Class I |