Identity
- Trade Name
- Fundus Camera FDA UDI
- Generic Name
- Ophthalmic fundus camera FDA UDI
- Device Name
- This equipment adopts advanced opto-mechanical and electrical integration technology, and integrates fundus digital image acquisition and image processing system. It can display color fundus images continuously, real-time and high-quality.The fundus digital image acquisition and image processing system processes the static images of the fundus color images with full digital processing, completes real-time recording and storage, and can be used for image processing, inspection reports, graphic editing, and data retrieval management for medical record generation at any time. The size of the lesion can be measured and calculated, the image can be scaled, moved, and pasted, and the color of the image can be adjusted. The image data of the case can be exported to the U disk and attached to the patient's case, which can assist scientific research and teaching FDA UDI
- Model / Reference
- SK-680A FDA UDI
- Description
- This equipment adopts advanced opto-mechanical and electrical integration technology, and integrates fundus digital image acquisition and image processing system. It can display color fundus images continuously, real-time and high-quality.The fundus digital image acquisition and image processing system processes the static images of the fundus color images with full digital processing, completes real-time recording and storage, and can be used for image processing, inspection reports, graphic editing, and data retrieval management for medical record generation at any time. The size of the lesion can be measured and calculated, the image can be scaled, moved, and pasted, and the color of the image can be adjusted. The image data of the case can be exported to the U disk and attached to the patient's case, which can assist scientific research and teaching FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973211070008 FDA UDI
- FDA Product Code
- PJZ FDA UDI
- GMDN Term
- Ophthalmic fundus camera FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.1120 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ophthalmic fundus camera
Fundus Camera by Chongqing Sunkingdom Medical Instrument Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Chongqing Sunkingdom Medical Instrument Co., Ltd
Sources (1)
- FDA UDI 22d2ec12-ce5f-4e93-81a3-e916a08f549c 33 fields · synced May 30, 2026