This company has registrations in United States, Brazil, Saudi Arabia, Canada, South Korea, Australia, Israel — 7 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 | K233225 | SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope) | 2024-06-20 |
| US | K221591 | Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source | 2023-02-23 |
| US | K201617 | TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU)) | 2021-03-12 |
| BR | 10302869015 | Endoscópio para Artroscopia Mistra | Class II |
| BR | 80370829037 | Artroscópio | Class II |
| BR | 10302869023 | Endoscopio para Sinuscopia Mistra | Class II |
| SA | ME0000014755SFDAA00003 | Controller 4K UHD USB Image Video Capture | — |
| SA | ME0000014755SFDAA00003 | Controller 4K UHD USB Image Video Capture | — |
| CA | 94083 | FLEXILUX II LARYNGO-PHARYNGOSCOPE | Class II |
| CA | 94084 | FLEXILUX II HYSTEROSCOPES | Class II |
| CA | 94086 | NASO-PHARYNGOSCOPE | Class II |