This company has registrations in United States, Brazil, Singapore, Australia — 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 | K261672 | twiist Automated Insulin Delivery (AID) System | 2026-06-17 |
| US | K261530 | iiSure Infusion Set | 2026-06-03 |
| US | K243841 | Sparta Infusion Set for Insulin | 2025-08-01 |
| BR | 80022069067 | Vídeoendoscópio | Class II |
| BR | 10317490199 | SU-1 PROCESSADOR DE ULTRASSONS | Class II |
| BR | 80022069065 | Endoscópio ultrassônico | Class II |