Eu Mdd Eu Md Class 2b On The Market 🇮🇱 Israel

EndoArt®

EyeYon Medical Ltd. · 🇮🇱 Israel
Devices (same UDI-DI)
1
Certificates
1
Countries
4
Notified Bodies
1

Basic Information

Primary DI
17290016352112
Basic UDI-DI Code
B-17290016352112
Reference
EARRXXYYZZZ
Device Types
Single use Sterile
Regulation
Eu Mdd
Classification
Eu Md Class 2b
Status
On The Market
Manufacturer
EyeYon Medical Ltd.

Additional Description

EndoArt® (Artificial Endothelial layer) is a permanent synthetic implant. The device serves as an inert physical barrier, blocking the ingress of fluid from the Anterior Chamber (AC) into the cornea. By sealing part of the inner cornea, the EndoArt® relieves corneal edema without functioning endothelium. The EndoArt® device is a copolymer of hydroxyethyl methacrylate and methyl methacrylate. It is dome shaped, optically clear, transparent, foldable implant, made of hydrophilic material designed to adhere to the posterior portion of the cornea.

CND Nomenclature Codes

Code Description
Q020299 CORNEA EXPLANTATION AND TRANSPLANTATION DEVICES - OTHER

Certificates

Type Number
MDD Annex II (excluding section 4) 7406GB410210510A

Available In Countries

🇦🇹 Austria 🇩🇪 Germany 🇫🇷 France 🇮🇹 Italy

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