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Image Processing Unit
EUDAMEDFDA UDIClass I (EU MDR)
Ref 71-068-05 NIRModel OPTO-CAM214K,71-068-05 NIR,71-068-05 NIR-CA
Identity
- Trade Name
- Image Processing Unit EUDAMEDVEQTRON FDA UDI
- Generic Name
- Stationary general-purpose fluoroscopic x-ray system, digital FDA UDI
- Device Name
- Image Processing Unit EUDAMEDVEQTRON ICG/NIR 4K UHD Endoscopic Fluorescence Imaging System, 4 CMOS, Camera Control Unit FDA UDI
- Model / Reference
- OPTO-CAM214K,71-068-05 NIR,71-068-05 NIR-CA EUDAMED71-068-05 NIR EUDAMEDFDA UDI
- Description
- VEQTRON ICG/NIR 4K UHD Endoscopic Fluorescence Imaging System, 4 CMOS, Camera Control Unit FDA UDI
Identifiers
- Catalog Number
- 71-068-05 NIR FDA UDI
- Primary DI / UDI-DI
- 06973031299702 EUDAMEDFDA UDI
- Basic UDI-DI
- 697303129CAM0000298 EUDAMED
- 510(k) Number
- K221861 FDA UDI
- FDA Product Code
- GCJ FDA UDIIZI FDA UDI
- EMDN Code
- Z12020406 VIDEO PROCESSORS EUDAMED
- GMDN Term
- Stationary general-purpose fluoroscopic x-ray system, digital FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI892.1600 FDA UDI
- Market of Registration
- Ireland 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
No
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
Image Processing Unit by Guangdong Optomedic Technologies, 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 | 697303129CAM0000298 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Guangdong Optomedic Technologies, Inc.
- EUDAMED SRN
- CN-MF-000011588
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (2)
- EUDAMED 3e9eb11a-324e-4478-abe7-ca77a4a5c1c0 61 fields · synced Jun 6, 2026
- FDA UDI ad22045d-7091-468a-998d-e5c9e4e20c0c 35 fields · synced May 29, 2026