Identity
- Trade Name
- Omni EUDAMEDFDA UDI
- Generic Name
- Endoscope video camera FDA UDI
- Device Name
- 4K HDR Camera System EUDAMEDOMNI 4K HDR SYSTEM, CAMERA HEAD, INTEGRATED, 1C FDA UDI
- Model / Reference
- 83-10-5120 EUDAMEDFDA UDI
- Description
- OMNI 4K HDR SYSTEM, CAMERA HEAD, INTEGRATED, 1C FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812231034439 EUDAMEDFDA UDI
- Basic UDI-DI
- 0812231038X-10-XXXXWW EUDAMED
- Direct Marketing DI
- 00812231034439 EUDAMED
- FDA Product Code
- GCJ FDA UDI
- EMDN Code
- Z12020405 SURGICAL CAMERAS EUDAMED
- GMDN Term
- Endoscope video camera FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Omni by Santa Barbara Imaging Systems, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0812231038X-10-XXXXWW | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Santa Barbara Imaging Systems, Inc.
- EUDAMED SRN
- US-MF-000007262
- Authorised Representative
- Qualrep Services B.V. NL-AR-000000537
Sources (2)
- EUDAMED 4ba90484-9d63-4d49-b8fd-76abcd8e9ba0 61 fields · synced Jun 8, 2026
- FDA UDI 6e4e1013-06b8-4501-841d-078685ace4a3 34 fields · synced May 29, 2026