This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Israel, Russia — 8 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 | K252457 | Disposable Distal End Tape Hood | 2026-01-30 |
| US | K243535 | Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U) | 2025-03-07 |
| US | K241532 | Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100) | 2024-10-22 |
| BR | 10413969032 | Colangioscópio Flexível Eletrônico Descartável - Percutâneo | Class II |
| BR | 10413969035 | Coledocoscópio Flexível Eletrônico Descartável Endoscópico | Class II |
| BR | 10413969021 | Sistema Eletrônico de Coledocoscópio Flexível / Cisto-Ureteroscópio | Class II |