This company has registrations in United States, Canada — 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 | K243676 | Duet External Drainage and Monitoring System (EDMS) | 2025-03-10 |
| US | K242034 | Duet External Drainage and Monitoring System (EDMS) | 2024-10-24 |
| US | K212641 | StrataMR II Valves and Shunts | 2021-09-16 |
| CA | 10378 | ALGOLINE CATHETER | Class IV |
| CA | 10444 | IMPORT PRODUCTS | Class III |
| CA | 11088 | RIVAS VASCULAR CATHETERS | Class IV |