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 | K243175 | Disposable Intermittent Catheter (TPU Catheter) | 2025-06-26 |
| US | K212567 | PVC Hydrophilic Urethral Catheter | 2022-12-07 |
| BR | 81231559039 | Sonda Foley Látex Hidrofílica | Class II |
| BR | 80212340050 | Cateter Urinário Biobase | Class I |
| BR | 81231559040 | Sonda Foley Silicone | Class II |