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    <manufacturerName>Advanced Photochromics LLC</manufacturerName>
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    <authorisedRepresentativeName>INDIZEN OPTICAL TECHNOLOGIES S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000042818</authorisedRepresentativeSrn>
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    <basicUdiDi>081016109NeoChromesUB</basicUdiDi>
    <tradeName>IOT Neochromes Poly HC SFSV Brown 75 8</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Advanced Photochromics LLC</manufacturerName>
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    <authorisedRepresentativeName>INDIZEN OPTICAL TECHNOLOGIES S.L.U</authorisedRepresentativeName>
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    <udiDi>08906211440029</udiDi>
    <basicUdiDi>890621144156HMCFSVA9</basicUdiDi>
    <tradeName>Hard Multi Coat</tradeName>
    <deviceName>Hard Multi Coat Single Vision Ophthalmic Lens</deviceName>
    <manufacturerName>NEW OPTICS</manufacturerName>
    <manufacturerSrn>IN-MF-000051780</manufacturerSrn>
    <authorisedRepresentativeName>New Optics OÜ</authorisedRepresentativeName>
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    <emdnCode>Q0210010101</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>10005</reference>
    <placedOnMarketCountry>Estonia</placedOnMarketCountry>
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    <basicUdiDi>890621144161BCFSVV4</basicUdiDi>
    <tradeName>Blue Cut</tradeName>
    <deviceName>Blue Cut Single Vision Ophthalmic Lens</deviceName>
    <manufacturerName>NEW OPTICS</manufacturerName>
    <manufacturerSrn>IN-MF-000051780</manufacturerSrn>
    <authorisedRepresentativeName>New Optics OÜ</authorisedRepresentativeName>
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    <emdnCode>Q0210010101</emdnCode>
    <emdnDescription>MONOFOCAL ORGANIC OPHTHALMIC LENSES</emdnDescription>
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    <reference>10011</reference>
    <placedOnMarketCountry>Estonia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:54:44.421Z</lastUpdated>
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    <udiDi>08809839940011</udiDi>
    <basicUdiDi>88098399400116231000000A5</basicUdiDi>
    <tradeName>COVIS LENS</tradeName>
    <deviceName>OPTICAL LENS</deviceName>
    <manufacturerName>COVIS OPTIC CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000038914</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0210010101</emdnCode>
    <emdnDescription>MONOFOCAL ORGANIC OPHTHALMIC LENSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Index 1.49, 1.56, 1.60, 1.67, 1.74 and Photochromic Lens</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:00:22.771Z</lastUpdated>
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    <udiDi>08808995540004</udiDi>
    <basicUdiDi>880899554000PU</basicUdiDi>
    <tradeName>1.56TINTED</tradeName>
    <deviceName>1.56TINTED</deviceName>
    <manufacturerName>KOREA OPTICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000008719</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0210010101</emdnCode>
    <emdnDescription>MONOFOCAL ORGANIC OPHTHALMIC LENSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1.56TINTED</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:44:29.113Z</lastUpdated>
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    <basicUdiDi>880899536000PL</basicUdiDi>
    <tradeName>1.60PHOTO</tradeName>
    <deviceName>1.60PHOTO</deviceName>
    <manufacturerName>KOREA OPTICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000008719</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0210010101</emdnCode>
    <emdnDescription>MONOFOCAL ORGANIC OPHTHALMIC LENSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1.60PHOTO</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:44:26.706Z</lastUpdated>
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    <manufacturerName>KOREA OPTICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000008719</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
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    <emdnCode>Q0210010101</emdnCode>
    <emdnDescription>MONOFOCAL ORGANIC OPHTHALMIC LENSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1.56PHOTO</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:44:25.139Z</lastUpdated>
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    <basicUdiDi>880899526000P9</basicUdiDi>
    <tradeName>1.74AS UV420 BRC</tradeName>
    <deviceName>1.74AS UV420 BRC</deviceName>
    <manufacturerName>KOREA OPTICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000008719</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0210010101</emdnCode>
    <emdnDescription>MONOFOCAL ORGANIC OPHTHALMIC LENSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1.74AS UV420 BRC</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:44:24.302Z</lastUpdated>
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    <udiDi>08808995240003</udiDi>
    <basicUdiDi>880899524000NT</basicUdiDi>
    <tradeName>1.74UV AS</tradeName>
    <deviceName>1.74UV AS</deviceName>
    <manufacturerName>KOREA OPTICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000008719</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0210010101</emdnCode>
    <emdnDescription>MONOFOCAL ORGANIC OPHTHALMIC LENSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1.74UV AS</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:44:22.707Z</lastUpdated>
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    <udiDi>08808995180002</udiDi>
    <basicUdiDi>880899518000PC</basicUdiDi>
    <tradeName>1.67AS UV420 BRC</tradeName>
    <deviceName>1.67AS UV420 BRC</deviceName>
    <manufacturerName>KOREA OPTICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000008719</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0210010101</emdnCode>
    <emdnDescription>MONOFOCAL ORGANIC OPHTHALMIC LENSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1.67AS UV420 BRC</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:44:20.314Z</lastUpdated>
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    <udiDi>08808995160004</udiDi>
    <basicUdiDi>880899516000NW</basicUdiDi>
    <tradeName>1.67UV AS</tradeName>
    <deviceName>1.67UV AS</deviceName>
    <manufacturerName>KOREA OPTICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000008719</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0210010101</emdnCode>
    <emdnDescription>MONOFOCAL ORGANIC OPHTHALMIC LENSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1.67UV AS</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:44:18.708Z</lastUpdated>
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    <udiDi>08808995140006</udiDi>
    <basicUdiDi>880899514000NG</basicUdiDi>
    <tradeName>1.60UV AS</tradeName>
    <deviceName>1.60UV AS</deviceName>
    <manufacturerName>KOREA OPTICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000008719</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0210010101</emdnCode>
    <emdnDescription>MONOFOCAL ORGANIC OPHTHALMIC LENSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1.60UV AS</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:44:17.903Z</lastUpdated>
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    <udiDi>08808995120008</udiDi>
    <basicUdiDi>880899512000N2</basicUdiDi>
    <tradeName>1.60UV420 BRC</tradeName>
    <deviceName>1.60UV420 BRC</deviceName>
    <manufacturerName>KOREA OPTICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000008719</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
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    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0210010101</emdnCode>
    <emdnDescription>MONOFOCAL ORGANIC OPHTHALMIC LENSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1.60UV420 BRC</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:44:16.302Z</lastUpdated>
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    <tradeName>1.60UV</tradeName>
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    <manufacturerName>KOREA OPTICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000008719</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
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    <emdnCode>Q0210010101</emdnCode>
    <emdnDescription>MONOFOCAL ORGANIC OPHTHALMIC LENSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1.60</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:44:13.899Z</lastUpdated>
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    <tradeName>1.56UV420 BRC</tradeName>
    <deviceName>1.56UV420 BRC</deviceName>
    <manufacturerName>KOREA OPTICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000008719</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>1.56UV420 BRC</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:44:12.299Z</lastUpdated>
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    <tradeName>1.56</tradeName>
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    <manufacturerName>KOREA OPTICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000008719</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
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    <riskClass>Sınıf I</riskClass>
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    <emdnCode>Q0210010101</emdnCode>
    <emdnDescription>MONOFOCAL ORGANIC OPHTHALMIC LENSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:44:11.494Z</lastUpdated>
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    <udiDi>08808995000003</udiDi>
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    <tradeName>1.499</tradeName>
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    <manufacturerName>KOREA OPTICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000008719</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
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    <riskClass>Sınıf I</riskClass>
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    <emdnCode>Q0210010101</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:44:09.900Z</lastUpdated>
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    <udiDi>08800138750639</udiDi>
    <basicUdiDi>88001387SOMO0001YP</basicUdiDi>
    <tradeName>1.50 SPHERICAL LENSES</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOMO INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000035075</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0210010101</emdnCode>
    <emdnDescription>MONOFOCAL ORGANIC OPHTHALMIC LENSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08800138750639</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:33:49.885Z</lastUpdated>
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    <udiDi>08606113110005</udiDi>
    <basicUdiDi>8606113110LensesSH</basicUdiDi>
    <tradeName>08606113110005</tradeName>
    <deviceName>prescription ophtalmic lenses</deviceName>
    <manufacturerName>SANI GROUP d.o.o.</manufacturerName>
    <manufacturerSrn>RS-MF-000048277</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0210010101</emdnCode>
    <emdnDescription>MONOFOCAL ORGANIC OPHTHALMIC LENSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>clear indeks 1.5</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:08:43.206Z</lastUpdated>
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