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PIxa
EUDAMEDFDA UDIClass I (EU MDR)
Ref 85-10-5130Ref 85-10-1500TRef 85-10-5100
Identity
- Trade Name
- PIxa EUDAMEDFDA UDI
- Generic Name
- Endoscope video camera FDA UDIEndoscopic device remote control FDA UDI
- Device Name
- 4K HDR Camera System EUDAMEDPixa 4K HDR System, Camera Head, Integrated, 3C FDA UDIPixa 4K HDR System, Camera Head, C-Mount, 3C FDA UDIPixa 4K HDR Tablet, Tethered FDA UDI
- Model / Reference
- 85-10-5130 EUDAMEDFDA UDI85-10-1500T EUDAMEDFDA UDI85-10-5100 EUDAMEDFDA UDI
- Description
- Pixa 4K HDR System, Camera Head, Integrated, 3C FDA UDIPixa 4K HDR System, Camera Head, C-Mount, 3C FDA UDIPixa 4K HDR Tablet, Tethered FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812231033876 EUDAMEDFDA UDI00812231034927 EUDAMEDFDA UDI00812231033883 EUDAMEDFDA UDI
- Basic UDI-DI
- 0812231038X-10-XXXXWW EUDAMED
- Direct Marketing DI
- 00812231033876 EUDAMED00812231033883 EUDAMED
- FDA Product Code
- GCJ FDA UDI
- EMDN Code
- Z12020405 SURGICAL CAMERAS EUDAMEDZ12020404 REMOTE CONTROL UNITS FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY EUDAMED
- GMDN Term
- Endoscope video camera FDA UDIEndoscopic device remote control 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
PIxa 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 (8)
- EUDAMED 701fbccc-1383-4f65-bc03-70fa51e24594 61 fields · synced Jul 27, 2026
- EUDAMED d63e66f4-2928-4bd9-a3f8-2dfed3d1527c 61 fields · synced May 18, 2026
- EUDAMED 47f81568-deff-49c6-9c97-77f5a69ca216 61 fields · synced May 19, 2026
- FDA UDI ec2f5812-5fba-47fd-aaf3-26a4341d6a4e 34 fields · synced May 30, 2026
- FDA UDI 9b7ce7b0-d36a-4bef-bc07-5fb6a96bacee 34 fields · synced May 30, 2026
- FDA UDI 73fa45ee-69de-4738-a4e2-bd30a1e636ef 34 fields · synced May 30, 2026
- EUDAMED 3856a451-c505-4dba-80c8-e1ad4e5e5c60 61 fields · synced Jun 20, 2026
- EUDAMED 7e8b7e72-a0f5-4167-915e-3e3cbeb16605 61 fields · synced Jul 27, 2026