<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>++M519TEK0085F</udiDi>
    <basicUdiDi>B-++M519TEK0085F</basicUdiDi>
    <tradeName>Tek-Lens II</tradeName>
    <deviceName>Hydrophilic Acrylic Intraocular lens</deviceName>
    <manufacturerName>Tekia, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020955</manufacturerSrn>
    <authorisedRepresentativeName>CALICEOS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000009387</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P030101030102</emdnCode>
    <emdnDescription>IOLs, PHAKIC, MONOFOCAL, SPHERICAL, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>872S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:54:08.249Z</lastUpdated>
  </row>
  <row>
    <udiDi>++M519TEK0095H</udiDi>
    <basicUdiDi>B-++M519TEK0095H</basicUdiDi>
    <tradeName>Tek-Lens II</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tekia, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020955</manufacturerSrn>
    <authorisedRepresentativeName>CALICEOS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000009387</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P030101030102</emdnCode>
    <emdnDescription>IOLs, PHAKIC, MONOFOCAL, SPHERICAL, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>872YS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:54:05.856Z</lastUpdated>
  </row>
</eudamedExport>