Pure Global AI
EUDAMED registration 08809938614103No

Soft Contact Lens

Medios.LtdClass IIaEU EUDAMEDTrade name: CUBE-i 38
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class IIa
CND nomenclatures code
Q0210040102
Trade name
CUBE-i 38
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
08809938614103
Basic UDI
88061529CUBEI38QH
Version date
March 15, 2023
Manufacturer last update
August 31, 2022
Active status
No
Manufacturer
Manufacturer name
Medios.Ltd
Country
Republic of Korea
Country type
NON_EU
Address
Daejeon
Email
sgji@mymedios.com
Authorized representative
Name
KTR Europe GmbH
SRN
DE-AR-000005685
Country
Germany
Address
77 Mergenthalerallee Eschborn
Email
ktreurope@ktreurope.de
Telephone
+49 6196 887 170
Regulatory information
Competent authority
DE/CA29 - Regierungspräsidium Darmstadt Abteilung Arbeitsschutz und Umwelt
Applicable legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed on the market
Germany
Market available
Germany:2022-03-28~2023-03-15
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

CONTACT LENSES - HYDROGEL, REUSABLE

About this record

Access comprehensive regulatory information for Soft Contact Lens in the European Union medical device market through Pure Global AI's free database. This Class IIa device is registered with EU EUDAMED under Primary DI 08809938614103 and manufactured by Medios.Ltd in Republic of Korea.

This page provides complete registration details including trade name (CUBE-i 38), manufacturer information, authorized representative details, competent authority (DE/CA29 - Regierungspräsidium Darmstadt Abteilung Arbeitsschutz und Umwelt), and regulatory compliance data from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry, helping global MedTech companies navigate EU MDR regulations efficiently.