Eu Mdr Eu Md Class 2a On The Market 🇰🇷 South Korea

OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE

VUNO Inc. · 🇰🇷 South Korea
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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