<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00844369027106</udiDi>
    <basicUdiDi>B-00844369027106</basicUdiDi>
    <tradeName>Softec HD™</tradeName>
    <deviceName>Softec HD</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>P030102090202</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Softec HD™</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:05:26.681Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844369027090</udiDi>
    <basicUdiDi>B-00844369027090</basicUdiDi>
    <tradeName>Softec HD™</tradeName>
    <deviceName>Softec HD</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>P030102090202</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Softec HD™</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:05:25.889Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844369027083</udiDi>
    <basicUdiDi>B-00844369027083</basicUdiDi>
    <tradeName>Softec HD™</tradeName>
    <deviceName>Softec HD</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>P030102090202</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Softec HD™</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:05:25.083Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844369027076</udiDi>
    <basicUdiDi>B-00844369027076</basicUdiDi>
    <tradeName>Softec HD™</tradeName>
    <deviceName>Softec HD</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>P030102090202</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Softec HD™</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:05:24.288Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844369027069</udiDi>
    <basicUdiDi>B-00844369027069</basicUdiDi>
    <tradeName>Softec HD™</tradeName>
    <deviceName>Softec HD</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>P030102090202</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Softec HD™</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:05:20.274Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844369027045</udiDi>
    <basicUdiDi>B-00844369027045</basicUdiDi>
    <tradeName>Softec HD™</tradeName>
    <deviceName>Softec HD</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>P030102090202</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Softec HD™</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:05:19.474Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844369027038</udiDi>
    <basicUdiDi>B-00844369027038</basicUdiDi>
    <tradeName>Softec HD™</tradeName>
    <deviceName>Softec HD</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>P030102090202</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Softec HD™</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:05:18.681Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844369027021</udiDi>
    <basicUdiDi>B-00844369027021</basicUdiDi>
    <tradeName>Softec HD™</tradeName>
    <deviceName>Softec HD™</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>P030102090202</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Softec HD™</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:05:17.880Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844369027014</udiDi>
    <basicUdiDi>B-00844369027014</basicUdiDi>
    <tradeName>Softec HD™</tradeName>
    <deviceName>Softec HD™</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>P030102090202</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Softec HD™</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:05:13.873Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844369027007</udiDi>
    <basicUdiDi>B-00844369027007</basicUdiDi>
    <tradeName>Softec HD™</tradeName>
    <deviceName>Softec HD™</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>P030102090202</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Softec HD™</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:05:13.075Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844369026734</udiDi>
    <basicUdiDi>B-00844369026734</basicUdiDi>
    <tradeName>Softec HDY™</tradeName>
    <deviceName>Softec HDY</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>P030102090202</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Softec HDY™</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:05:12.270Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844369026727</udiDi>
    <basicUdiDi>B-00844369026727</basicUdiDi>
    <tradeName>Softec HDY™</tradeName>
    <deviceName>Softec HDY</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>P030102090202</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Softec HDY™</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:05:11.476Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844369026710</udiDi>
    <basicUdiDi>B-00844369026710</basicUdiDi>
    <tradeName>Softec HDY™</tradeName>
    <deviceName>Softec HDY</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>P030102090202</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Softec HDY™</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:05:07.468Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844369026703</udiDi>
    <basicUdiDi>B-00844369026703</basicUdiDi>
    <tradeName>Softec HDY™</tradeName>
    <deviceName>Softec HDY</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>P030102090202</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Softec HDY™</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:05:06.667Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844369026697</udiDi>
    <basicUdiDi>B-00844369026697</basicUdiDi>
    <tradeName>Softec HDY™</tradeName>
    <deviceName>Softec HDY</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>P030102090202</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Softec HDY™</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:05:05.867Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844369026680</udiDi>
    <basicUdiDi>B-00844369026680</basicUdiDi>
    <tradeName>Softec HDY™</tradeName>
    <deviceName>Softec HDY</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>P030102090202</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Softec HDY™</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:05:05.068Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844369026673</udiDi>
    <basicUdiDi>B-00844369026673</basicUdiDi>
    <tradeName>Softec HDY™</tradeName>
    <deviceName>Softec HDY</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>P030102090202</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Softec HDY™</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:05:01.067Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844369026666</udiDi>
    <basicUdiDi>B-00844369026666</basicUdiDi>
    <tradeName>Softec HDY™</tradeName>
    <deviceName>Softec HDY</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>P030102090202</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Softec HDY™</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:05:00.264Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844369026659</udiDi>
    <basicUdiDi>B-00844369026659</basicUdiDi>
    <tradeName>Softec HDY™</tradeName>
    <deviceName>Softec HDY</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>P030102090202</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Softec HDY™</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:04:59.466Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844369026642</udiDi>
    <basicUdiDi>B-00844369026642</basicUdiDi>
    <tradeName>Softec HDY™</tradeName>
    <deviceName>Softec HDY</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>P030102090202</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Softec HDY™</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:04:58.665Z</lastUpdated>
  </row>
</eudamedExport>