This company has registrations in United States, Brazil, Canada, Singapore, Israel — 5 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 | K241956 | Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2) | 2025-01-22 |
| US | K231107 | Bronchoscope System | 2024-02-15 |
| US | K231725 | Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R) | 2023-10-16 |
| BR | 82195309098 | Cistoscópio flexível digital | Class II |
| BR | 82195309083 | Processador de Imagens Endoscópicas | Class II |
| BR | 82195309080 | Ureteroscópio flexível digital | Class II |