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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 | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 7406GB410210510A | DNV MEDCERT GmbH | Expired |
Available In Countries
Similar Devices
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