This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Singapore, South Korea, Australia, Hong Kong, Israel — 10 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 |
|---|---|---|---|
| EU | 06975339626266 | ViewHub | Class I |
| EU | 06975339626259 | — | Class I |
| EU | 06975339625269 | GorgeView | Class IIa |
| EU | 06975339625252 | GorgeView | Class IIa |
| UK | 18034 | Video Processor | Class I |
| UK | 60963 | Single Use Digital Flexible Bronchoscope | Class IIa |
| UK | 61728 | Single Use Digital Flexible Cystoscope | Class IIa |
| US | K260516 | BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR) | 2026-07-20 |
| US | K260420 | LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG) | 2026-04-08 |
| US | K250452 | CoralWell Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0855B, NS-0935B, NS-0940B, NS-0945B, NS-0955B, NS-1035B, NS-1040B, NS-1045B, NS-1055B, NS-1135B, NS-1140B, NS-1145B, NS-1155B, NS-1235B, NS-1240B, NS-1245B, NS-1255B, NS-1335B, NS-1340B, NS-1345B, NS-1355B, NS-1435B, NS-1440B, NS-1445B, NS-1455B) | 2025-06-02 |
| BR | 82195309097 | Broncoscópio Flexível Digital de Uso Único LoopView | Class II |
| BR | 82195309084 | Histeroscópio Digital de Uso Único SeleneView | Class II |
| BR | 82195309060 | CoralWell Bainha de Acesso Ureteral de Uso Único | Class II |