Eu Mdr
Eu Md Class 2a
On The Market
🇰🇷 South Korea
OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE
Devices (same UDI-DI)
1
Certificates
0
Countries
1
Notified Bodies
0
Basic Information
- Primary DI
- 08800045800076
- Basic UDI-DI Code
- 88000458VFSZ7
- Reference
- VN-M-03
- Device Types
- None provided
- Regulation
- Eu Mdr
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- VUNO Inc.
Additional Description
The software consists of automated screening tools based on an artificial intelligence(AI) algorithm intended to aid healthcare professionals in detecting retinal findings on fundus image.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z12120192 | OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE |
Available In Countries
🇪🇸 Spain
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