Eu Mdd Eu Md Class 2a On The Market ๐Ÿ‡ฎ๐Ÿ‡ฑ Israel

Hyper-CL

EyeYon Medical Ltd. ยท ๐Ÿ‡ฎ๐Ÿ‡ฑ Israel
Devices (same UDI-DI)
1
Certificates
1
Countries
3
Notified Bodies
1

Basic Information

Primary DI
17290016352228
Basic UDI-DI Code
B-17290016352228
Reference
KIT-003-EU
Device Types
Single use Sterile
Regulation
Eu Mdd
Classification
Eu Md Class 2a
Status
On The Market
Manufacturer
EyeYon Medical Ltd.

Additional Description

The Hyper-CLโ„ข therapeutic contact lens integrates an innovative design featuring two main base curves, a groove and fenestrations. The fenestrations increase tear film exchange between the cornea and the contact lens and enable entry of the instilled drops into the groove and lens reservoir. The internal groove connected to the anterior surface via fenestrations, acts as a reservoir in addition to the central reservoir, both of which create a cavity between the lens and the cornea that retains any applied eye drop for a prolonged period of time, enhancing its effectiveness. In this manner, they increase the accessibility and overall contact time of ophthalmic solutions (drops) with the center of the cornea, as well as increase oxygen permeability.

CND Nomenclature Codes

Code Description
Q021004010102 CONTACT LENSES - HYDROGEL, EXTENDED SINGLE-USE

Certificates

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

Available In Countries

๐Ÿ‡ฉ๐Ÿ‡ช Germany ๐Ÿ‡ช๐Ÿ‡ธ Spain ๐Ÿ‡ฎ๐Ÿ‡น Italy

Similar Devices

Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDD).

View all