Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 08800065600014
- Basic UDI-DI Code
- 8800065600014XH
- Reference
- 08800065600014
- Device Types
- None provided
- Regulation
- Eu Mdr
- Classification
- Eu Md Class 1
- Status
- On The Market
- Manufacturer
- WikiOptics Inc.
Additional Description
The WFC 01 is a medical device that observes and records the retina of humans or animals. Users can focus on the retinal surface by manually focusing the knob viewing with an IR light source and getting the visible image with a white LED flash. So, there is no need to use any pupil dilation agent. Using the user’s Android OS smartphone, the user can view the retinal image and control the level of lighting, etc.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z12120199 | OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER |
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