Identity
- Trade Name
- Omni EUDAMEDFDA UDI
- Generic Name
- Endoscopic device remote control FDA UDIEndoscopic video image processing unit FDA UDI
- Device Name
- 4K HDR Camera System EUDAMEDOMNI 4K HDR SYSTEM, TABLET FDA UDIOMNI 4K HDR SYSTEM, CAMERA CONTROL UNIT WITH IMAGE CAPTURE & LIGHT ENGINE FDA UDI
- Model / Reference
- 83-10-5001 EUDAMEDFDA UDI83-10-1500 EUDAMEDFDA UDI
- Description
- OMNI 4K HDR SYSTEM, TABLET FDA UDIOMNI 4K HDR SYSTEM, CAMERA CONTROL UNIT WITH IMAGE CAPTURE & LIGHT ENGINE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812231034415 EUDAMEDFDA UDI00812231034453 EUDAMEDFDA UDI
- Basic UDI-DI
- 0812231038X-10-XXXXWW EUDAMED
- FDA Product Code
- GCJ FDA UDI
- EMDN Code
- Z12020401 INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES EUDAMEDZ12020404 REMOTE CONTROL UNITS FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY EUDAMED
- GMDN Term
- Endoscopic device remote control FDA UDIEndoscopic video image processing unit 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
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 (6)
- EUDAMED a662cf1c-d655-46bb-9b71-46be57e9565f 61 fields · synced Jul 29, 2026
- EUDAMED c8df3ba4-91b4-4f19-afa2-70ae82703a1d 61 fields · synced May 19, 2026
- FDA UDI de6706a9-7a76-48f4-aa47-7ee57e2798b1 34 fields · synced May 30, 2026
- FDA UDI 687e127b-9419-4ecb-b5e0-25158f7d18db 34 fields · synced May 30, 2026
- EUDAMED 79ba3c49-e12c-4f56-84c0-fe30944eb6f9 61 fields · synced Jul 12, 2026
- EUDAMED 18bec326-399e-419b-bc15-b8d2c9452713 61 fields · synced Jul 29, 2026