<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>++M519TEK0155C</udiDi>
    <basicUdiDi>B-++M519TEK0155C</basicUdiDi>
    <tradeName>Tek-Clear</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>P030102090102</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, SPHERICAL, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>500S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:56:11.690Z</lastUpdated>
  </row>
  <row>
    <udiDi>08907745968058</udiDi>
    <basicUdiDi>B-08907745968058</basicUdiDi>
    <tradeName>OcuFlex</tradeName>
    <deviceName>OcuFlex</deviceName>
    <manufacturerName>Caregroup Sight Solution Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000024154</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P030102090102</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, SPHERICAL, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAT-00000HP00-A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-10T18:26:01.022Z</lastUpdated>
  </row>
  <row>
    <udiDi>08907745968041</udiDi>
    <basicUdiDi>B-08907745968041</basicUdiDi>
    <tradeName>OcuFlex</tradeName>
    <deviceName>OcuFlex</deviceName>
    <manufacturerName>Caregroup Sight Solution Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000024154</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P030102090102</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, SPHERICAL, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAT-00000HP00-A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-10T18:25:59.204Z</lastUpdated>
  </row>
  <row>
    <udiDi>08907745968034</udiDi>
    <basicUdiDi>B-08907745968034</basicUdiDi>
    <tradeName>OcuFlex</tradeName>
    <deviceName>OcuFlex</deviceName>
    <manufacturerName>Caregroup Sight Solution Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000024154</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P030102090102</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, SPHERICAL, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAT-00000HP00-A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-10T18:25:58.964Z</lastUpdated>
  </row>
  <row>
    <udiDi>08907745968027</udiDi>
    <basicUdiDi>B-08907745968027</basicUdiDi>
    <tradeName>OcuFlex</tradeName>
    <deviceName>OcuFlex</deviceName>
    <manufacturerName>Caregroup Sight Solution Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000024154</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P030102090102</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, SPHERICAL, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAT-00000HP00-A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-10T18:25:56.014Z</lastUpdated>
  </row>
  <row>
    <udiDi>08907745968010</udiDi>
    <basicUdiDi>B-08907745968010</basicUdiDi>
    <tradeName>OcuFlex</tradeName>
    <deviceName>OcuFlex</deviceName>
    <manufacturerName>Caregroup Sight Solution Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000024154</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P030102090102</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, SPHERICAL, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAT-00000HP00-A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-10T18:25:53.608Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844369029940</udiDi>
    <basicUdiDi>B-00844369029940</basicUdiDi>
    <tradeName>Softec I™</tradeName>
    <deviceName>Softec I</deviceName>
    <manufacturerName>Lenstec (Barbados) Inc.</manufacturerName>
    <manufacturerSrn>BB-MF-000019262</manufacturerSrn>
    <authorisedRepresentativeName>CMI spol. s r.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SK-AR-000007425</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P030102090102</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, SPHERICAL, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Softec I™</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:12:14.376Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844369029933</udiDi>
    <basicUdiDi>B-00844369029933</basicUdiDi>
    <tradeName>Softec I™</tradeName>
    <deviceName>Softec I</deviceName>
    <manufacturerName>Lenstec (Barbados) Inc.</manufacturerName>
    <manufacturerSrn>BB-MF-000019262</manufacturerSrn>
    <authorisedRepresentativeName>CMI spol. s r.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SK-AR-000007425</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P030102090102</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, SPHERICAL, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Softec I™</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:12:13.577Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844369029926</udiDi>
    <basicUdiDi>B-00844369029926</basicUdiDi>
    <tradeName>Softec I™</tradeName>
    <deviceName>Softec I</deviceName>
    <manufacturerName>Lenstec (Barbados) Inc.</manufacturerName>
    <manufacturerSrn>BB-MF-000019262</manufacturerSrn>
    <authorisedRepresentativeName>CMI spol. s r.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SK-AR-000007425</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P030102090102</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, SPHERICAL, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Softec I™</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:12:12.774Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844369029919</udiDi>
    <basicUdiDi>B-00844369029919</basicUdiDi>
    <tradeName>Softec I™</tradeName>
    <deviceName>Softec I</deviceName>
    <manufacturerName>Lenstec (Barbados) Inc.</manufacturerName>
    <manufacturerSrn>BB-MF-000019262</manufacturerSrn>
    <authorisedRepresentativeName>CMI spol. s r.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SK-AR-000007425</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P030102090102</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, SPHERICAL, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Softec I™</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:12:08.772Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844369029902</udiDi>
    <basicUdiDi>B-00844369029902</basicUdiDi>
    <tradeName>Softec I™</tradeName>
    <deviceName>Softec I</deviceName>
    <manufacturerName>Lenstec (Barbados) Inc.</manufacturerName>
    <manufacturerSrn>BB-MF-000019262</manufacturerSrn>
    <authorisedRepresentativeName>CMI spol. s r.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SK-AR-000007425</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P030102090102</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, SPHERICAL, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Softec I™</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:12:07.970Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844369029896</udiDi>
    <basicUdiDi>B-00844369029896</basicUdiDi>
    <tradeName>Softec I™</tradeName>
    <deviceName>Softec I</deviceName>
    <manufacturerName>Lenstec (Barbados) Inc.</manufacturerName>
    <manufacturerSrn>BB-MF-000019262</manufacturerSrn>
    <authorisedRepresentativeName>CMI spol. s r.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SK-AR-000007425</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P030102090102</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, SPHERICAL, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Softec I</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:12:07.174Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844369029889</udiDi>
    <basicUdiDi>B-00844369029889</basicUdiDi>
    <tradeName>Softec I™</tradeName>
    <deviceName>Softec I</deviceName>
    <manufacturerName>Lenstec (Barbados) Inc.</manufacturerName>
    <manufacturerSrn>BB-MF-000019262</manufacturerSrn>
    <authorisedRepresentativeName>CMI spol. s r.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SK-AR-000007425</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P030102090102</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, SPHERICAL, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Softec I™</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:12:06.371Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844369029872</udiDi>
    <basicUdiDi>B-00844369029872</basicUdiDi>
    <tradeName>Softec I™</tradeName>
    <deviceName>Softec I</deviceName>
    <manufacturerName>Lenstec (Barbados) Inc.</manufacturerName>
    <manufacturerSrn>BB-MF-000019262</manufacturerSrn>
    <authorisedRepresentativeName>CMI spol. s r.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SK-AR-000007425</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P030102090102</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, SPHERICAL, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Softec I™</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:12:02.367Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844369029865</udiDi>
    <basicUdiDi>B-00844369029865</basicUdiDi>
    <tradeName>Softec I™</tradeName>
    <deviceName>Softec I</deviceName>
    <manufacturerName>Lenstec (Barbados) Inc.</manufacturerName>
    <manufacturerSrn>BB-MF-000019262</manufacturerSrn>
    <authorisedRepresentativeName>CMI spol. s r.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SK-AR-000007425</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P030102090102</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, SPHERICAL, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Softec I™</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:12:01.585Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844369029858</udiDi>
    <basicUdiDi>B-00844369029858</basicUdiDi>
    <tradeName>Softec I™</tradeName>
    <deviceName>Softec I</deviceName>
    <manufacturerName>Lenstec (Barbados) Inc.</manufacturerName>
    <manufacturerSrn>BB-MF-000019262</manufacturerSrn>
    <authorisedRepresentativeName>CMI spol. s r.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SK-AR-000007425</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P030102090102</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, SPHERICAL, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Softec I™</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:12:00.767Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844369029841</udiDi>
    <basicUdiDi>B-00844369029841</basicUdiDi>
    <tradeName>Softec I™</tradeName>
    <deviceName>Softec I</deviceName>
    <manufacturerName>Lenstec (Barbados) Inc.</manufacturerName>
    <manufacturerSrn>BB-MF-000019262</manufacturerSrn>
    <authorisedRepresentativeName>CMI spol. s r.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SK-AR-000007425</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P030102090102</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, SPHERICAL, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Softec I™</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:11:59.968Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844369029827</udiDi>
    <basicUdiDi>B-00844369029827</basicUdiDi>
    <tradeName>Softec I™</tradeName>
    <deviceName>Softec I</deviceName>
    <manufacturerName>Lenstec (Barbados) Inc.</manufacturerName>
    <manufacturerSrn>BB-MF-000019262</manufacturerSrn>
    <authorisedRepresentativeName>CMI spol. s r.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SK-AR-000007425</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P030102090102</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, SPHERICAL, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Softec I™</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:11:55.967Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844369029810</udiDi>
    <basicUdiDi>B-00844369029810</basicUdiDi>
    <tradeName>Softec I™</tradeName>
    <deviceName>Softec I</deviceName>
    <manufacturerName>Lenstec (Barbados) Inc.</manufacturerName>
    <manufacturerSrn>BB-MF-000019262</manufacturerSrn>
    <authorisedRepresentativeName>CMI spol. s r.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SK-AR-000007425</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P030102090102</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, SPHERICAL, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Softec I™</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:11:55.162Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844369029803</udiDi>
    <basicUdiDi>B-00844369029803</basicUdiDi>
    <tradeName>Softec I™</tradeName>
    <deviceName>Softec I</deviceName>
    <manufacturerName>Lenstec (Barbados) Inc.</manufacturerName>
    <manufacturerSrn>BB-MF-000019262</manufacturerSrn>
    <authorisedRepresentativeName>CMI spol. s r.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SK-AR-000007425</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P030102090102</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, SPHERICAL, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Softec I™</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:11:54.359Z</lastUpdated>
  </row>
</eudamedExport>