Manufacturer
Santa Barbara Imaging Systems
United StatesLegal entities : Santa Barbara Imaging Systems, Inc.
Markets : Austria · France · Netherlands · United States
Approvals : EU – class I · United States (FDA) – 510(k) : 2 · class I, II · latest in 2023 · see on the FDA website
EU representative : Qualrep Services B.V. (Netherlands)
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
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| Category | EMDN code | Registered models | Class | Contact |
|---|---|---|---|---|
| Instruments for the acquisition and management of endoscopic and minimally invasive surgery images - hardware accessories | Z12020480 |
|
I MDR | EUDAMED record Report an error |
| Integrated systems for the acquisition and management of endoscopic and minimally invasive surgery images | Z12020401 | I MDR | EUDAMED record Report an error |
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