This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 11 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 | K252492 | Visualized Access and Delivery Catheter; PB Digital Controller | 2026-04-24 |
| US | K251692 | Advanced Tissue Resection Device | 2026-02-21 |
| US | K250229 | Dual Action Tissue Closure Device | 2025-09-08 |
| BR | 10306840175 | Agulha de Aspiração Ecoendoscópica FNB | Class II |
| BR | 10306840164 | Pinça de Biopsia Descartável sem revestimento | Class II |
| BR | 10306849028 | Pinça de Biopsia AccuBite | Class II |
| SA | ME0000008810SFDAA00001 | Disposable Bite Block | — |
| SA | ME0000008810SFDAA00002 | Endoscopy Working Channel Valves | — |
| CA | 94947 | CLIP | Class II |
| CA | 94950 | INJECTION NEEDLE | Class II |
| CA | 112185 | LARGE CAPACITY DISPOSABLE BIOPSY FORCEPS | Class II |