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    <tradeName>Tetraflex™ HD</tradeName>
    <deviceName>Tetraflex 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>P030102110202</emdnCode>
    <emdnDescription>IOLs, APHAKIC, ACCOMMODATIVE, ASPHERIC, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>Tetraflex™ HD</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:12:27.192Z</lastUpdated>
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    <udiDi>00844369030069</udiDi>
    <basicUdiDi>B-00844369030069</basicUdiDi>
    <tradeName>Tetraflex™ HD</tradeName>
    <deviceName>Tetraflex 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>P030102110202</emdnCode>
    <emdnDescription>IOLs, APHAKIC, ACCOMMODATIVE, ASPHERIC, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>Tetraflex™ HD</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:12:26.390Z</lastUpdated>
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  <row>
    <udiDi>00844369030052</udiDi>
    <basicUdiDi>B-00844369030052</basicUdiDi>
    <tradeName>Tetraflex™ HD</tradeName>
    <deviceName>Tetraflex 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>P030102110202</emdnCode>
    <emdnDescription>IOLs, APHAKIC, ACCOMMODATIVE, ASPHERIC, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>Tetraflex™ HD</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:12:25.637Z</lastUpdated>
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  <row>
    <udiDi>00844369030045</udiDi>
    <basicUdiDi>B-00844369030045</basicUdiDi>
    <tradeName>Tetraflex™ HD</tradeName>
    <deviceName>Tetraflex 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>P030102110202</emdnCode>
    <emdnDescription>IOLs, APHAKIC, ACCOMMODATIVE, ASPHERIC, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>Tetraflex™ HD</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:12:21.587Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844369030038</udiDi>
    <basicUdiDi>B-00844369030038</basicUdiDi>
    <tradeName>Tetraflex™ HD</tradeName>
    <deviceName>Tetraflex 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>P030102110202</emdnCode>
    <emdnDescription>IOLs, APHAKIC, ACCOMMODATIVE, ASPHERIC, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>Tetraflex™ HD</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:12:20.788Z</lastUpdated>
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  <row>
    <udiDi>00844369030021</udiDi>
    <basicUdiDi>B-00844369030021</basicUdiDi>
    <tradeName>Tetraflex™ HD</tradeName>
    <deviceName>Tetraflex 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>P030102110202</emdnCode>
    <emdnDescription>IOLs, APHAKIC, ACCOMMODATIVE, ASPHERIC, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>Tetraflex™ HD</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:12:19.982Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844369030014</udiDi>
    <basicUdiDi>B-00844369030014</basicUdiDi>
    <tradeName>Tetraflex™ HD</tradeName>
    <deviceName>Tetraflex 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>P030102110202</emdnCode>
    <emdnDescription>IOLs, APHAKIC, ACCOMMODATIVE, ASPHERIC, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>Tetraflex™ HD</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:12:19.181Z</lastUpdated>
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  <row>
    <udiDi>00844369030007</udiDi>
    <basicUdiDi>B-00844369030007</basicUdiDi>
    <tradeName>Tetraflex™ HD</tradeName>
    <deviceName>Tetraflex 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>P030102110202</emdnCode>
    <emdnDescription>IOLs, APHAKIC, ACCOMMODATIVE, ASPHERIC, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>Tetraflex™ HD</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:12:15.204Z</lastUpdated>
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  <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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