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    <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>2026-07-05T05:09:12.522Z</lastUpdated>
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    <udiDi>00844369029032</udiDi>
    <basicUdiDi>B-00844369029032</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>2026-07-05T05:09:08.520Z</lastUpdated>
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    <udiDi>00844369029025</udiDi>
    <basicUdiDi>B-00844369029025</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>2026-07-05T05:09:07.717Z</lastUpdated>
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    <udiDi>00844369029018</udiDi>
    <basicUdiDi>B-00844369029018</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>2026-07-05T05:09:06.916Z</lastUpdated>
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  <row>
    <udiDi>00844369029001</udiDi>
    <basicUdiDi>B-00844369029001</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>2026-07-05T05:09:06.122Z</lastUpdated>
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  <row>
    <udiDi>00844369015493</udiDi>
    <basicUdiDi>B-00844369015493</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>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:02:26.362Z</lastUpdated>
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  <row>
    <udiDi>00844369015486</udiDi>
    <basicUdiDi>B-00844369015486</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>2026-07-05T05:02:24.766Z</lastUpdated>
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  <row>
    <udiDi>00814106016694</udiDi>
    <basicUdiDi>B-00814106016694</basicUdiDi>
    <tradeName>00814106016694</tradeName>
    <deviceName>880UV</deviceName>
    <manufacturerName>U.S. IOL, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000030660</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P030102090102</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, SPHERICAL, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>880UV</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:02:07.028Z</lastUpdated>
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  <row>
    <udiDi>00814106016267</udiDi>
    <basicUdiDi>B-00814106016267</basicUdiDi>
    <tradeName>00814106016267</tradeName>
    <deviceName>860UV</deviceName>
    <manufacturerName>U.S. IOL, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000030660</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P030102090102</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, SPHERICAL, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>860UV</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:00:46.110Z</lastUpdated>
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  <row>
    <udiDi>00814106016250</udiDi>
    <basicUdiDi>B-00814106016250</basicUdiDi>
    <tradeName>00814106016250</tradeName>
    <deviceName>860UV</deviceName>
    <manufacturerName>U.S. IOL, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000030660</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P030102090102</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, SPHERICAL, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>860UV</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:00:43.698Z</lastUpdated>
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  <row>
    <udiDi>00814106016236</udiDi>
    <basicUdiDi>B-00814106016236</basicUdiDi>
    <tradeName>00814106016236</tradeName>
    <deviceName>860UV</deviceName>
    <manufacturerName>U.S. IOL, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000030660</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P030102090102</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, SPHERICAL, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>860UV</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:00:42.110Z</lastUpdated>
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  <row>
    <udiDi>00814106016229</udiDi>
    <basicUdiDi>B-00814106016229</basicUdiDi>
    <tradeName>00814106016229</tradeName>
    <deviceName>860UV</deviceName>
    <manufacturerName>U.S. IOL, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000030660</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P030102090102</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, SPHERICAL, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>860UV</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:00:41.301Z</lastUpdated>
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  <row>
    <udiDi>00814106016243</udiDi>
    <basicUdiDi>B-00814106016243</basicUdiDi>
    <tradeName>00814106016243</tradeName>
    <deviceName>860UV</deviceName>
    <manufacturerName>U.S. IOL, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000030660</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P030102090102</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, SPHERICAL, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>860UV</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:00:39.697Z</lastUpdated>
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  <row>
    <udiDi>00814106011521</udiDi>
    <basicUdiDi>B-00814106011521</basicUdiDi>
    <tradeName>00814106011521</tradeName>
    <deviceName>860UV</deviceName>
    <manufacturerName>U.S. IOL, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000030660</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P030102090102</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, SPHERICAL, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>860UV</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:59:08.428Z</lastUpdated>
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    <udiDi>00814106011514</udiDi>
    <basicUdiDi>B-00814106011514</basicUdiDi>
    <tradeName>00814106011514</tradeName>
    <deviceName>860UV</deviceName>
    <manufacturerName>U.S. IOL, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000030660</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P030102090102</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, SPHERICAL, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>860UV</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:59:06.729Z</lastUpdated>
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    <udiDi>00814106011507</udiDi>
    <basicUdiDi>B-00814106011507</basicUdiDi>
    <tradeName>00814106011507</tradeName>
    <deviceName>860UV</deviceName>
    <manufacturerName>U.S. IOL, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000030660</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P030102090102</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, SPHERICAL, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>860UV</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:59:05.931Z</lastUpdated>
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    <udiDi>00814106011491</udiDi>
    <basicUdiDi>B-00814106011491</basicUdiDi>
    <tradeName>00814106011491</tradeName>
    <deviceName>860UV</deviceName>
    <manufacturerName>U.S. IOL, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000030660</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
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    <emdnCode>P030102090102</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, SPHERICAL, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>860UV</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:59:05.132Z</lastUpdated>
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    <udiDi>00814106011484</udiDi>
    <basicUdiDi>B-00814106011484</basicUdiDi>
    <tradeName>00814106011484</tradeName>
    <deviceName>860UV</deviceName>
    <manufacturerName>U.S. IOL, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000030660</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P030102090102</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, SPHERICAL, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>860UV</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:59:01.116Z</lastUpdated>
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    <udiDi>00814106011477</udiDi>
    <basicUdiDi>B-00814106011477</basicUdiDi>
    <tradeName>00814106011477</tradeName>
    <deviceName>860UV</deviceName>
    <manufacturerName>U.S. IOL, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000030660</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P030102090102</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, SPHERICAL, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>860UV</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:59:00.333Z</lastUpdated>
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    <udiDi>00814106011460</udiDi>
    <basicUdiDi>B-00814106011460</basicUdiDi>
    <tradeName>00814106011460</tradeName>
    <deviceName>860UV</deviceName>
    <manufacturerName>U.S. IOL, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000030660</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P030102090102</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, SPHERICAL, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>860UV</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:58:59.519Z</lastUpdated>
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