EUDAMED device
Omni
EUDAMED device 00812231034415 · Santa Barbara Imaging Systems, Inc.
Key facts
| Primary DI | 00812231034415 |
|---|---|
| Trade name | Omni |
| Device name | 4K HDR Camera System |
| Reference or catalog number | 83-10-5001 |
| Manufacturer | Santa Barbara Imaging Systems, Inc. |
| Manufacturer SRN | US-MF-000007262 |
| Risk class | Class I |
| EMDN code | Z12020401 |
| EMDN description | INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES |
| Legislation | mdr |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Dec 16, 2024 |
At a glance
- Yes Matching FDA GUDID record
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About EUDAMED devices
EUDAMED is the European Union's database of medical devices registered under the MDR and IVDR, including UDI-DIs, risk classes and EMDN nomenclature codes.
Source: European Commission, European Database on Medical Devices (EUDAMED) · Source date: