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    <deviceName>1.67 SemiFinished Camber lenses version One</deviceName>
    <manufacturerName>Advanced Photochromics LLC</manufacturerName>
    <manufacturerSrn>US-MF-000043049</manufacturerSrn>
    <authorisedRepresentativeName>INDIZEN OPTICAL TECHNOLOGIES S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000042818</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0210010101</emdnCode>
    <emdnDescription>MONOFOCAL ORGANIC OPHTHALMIC LENSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0265023978</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-30T16:54:25.462Z</lastUpdated>
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    <udiDi>18404975007351</udiDi>
    <basicUdiDi>081016109160CamberOnePW</basicUdiDi>
    <tradeName>Neochromes ONE HI 1.60 UC Camber Gray 0.50</tradeName>
    <deviceName>1.60 SemiFinished Camber lenses version One</deviceName>
    <manufacturerName>Advanced Photochromics LLC</manufacturerName>
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    <authorisedRepresentativeName>INDIZEN OPTICAL TECHNOLOGIES S.L.U</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>0265023754</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-30T16:54:24.770Z</lastUpdated>
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    <udiDi>18404975004435</udiDi>
    <basicUdiDi>081016109150SFSVOneE4</basicUdiDi>
    <tradeName>Neochromes ONE Hard Resin UC SFSV Gray 0.5</tradeName>
    <deviceName>1.50 SemiFinished Single Vision lenses version One</deviceName>
    <manufacturerName>Advanced Photochromics LLC</manufacturerName>
    <manufacturerSrn>US-MF-000043049</manufacturerSrn>
    <authorisedRepresentativeName>INDIZEN OPTICAL TECHNOLOGIES S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000042818</authorisedRepresentativeSrn>
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    <emdnCode>Q0210010101</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>0265020438</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-30T16:54:07.784Z</lastUpdated>
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    <udiDi>18404975002592</udiDi>
    <basicUdiDi>081016109PolySFSVOneBJ</basicUdiDi>
    <tradeName>Neochromes ONE Poly HC SFSV Gray 0.50</tradeName>
    <deviceName>Polycarbonate SemiFinished Single Vision lenses version One</deviceName>
    <manufacturerName>Advanced Photochromics LLC</manufacturerName>
    <manufacturerSrn>US-MF-000043049</manufacturerSrn>
    <authorisedRepresentativeName>INDIZEN OPTICAL TECHNOLOGIES S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000042818</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0210010101</emdnCode>
    <emdnDescription>MONOFOCAL ORGANIC OPHTHALMIC LENSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0265021311</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-30T16:54:07.077Z</lastUpdated>
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    <udiDi>06974993063738</udiDi>
    <basicUdiDi>697799306WR-S3951ML</basicUdiDi>
    <tradeName>READING GLASSES</tradeName>
    <deviceName></deviceName>
    <manufacturerName>WENZHOU WONDERFUL EYEWEAR CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000009784</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0210010102</emdnCode>
    <emdnDescription>MULTIFOCAL ORGANIC OPHTHALMIC LENSES (BIFOCAL, TRIFOCAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>697799306WR-S3951ML</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-24T11:19:52.867Z</lastUpdated>
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    <udiDi>D-UO27464STAXY</udiDi>
    <basicUdiDi>B-UO27464STAXY</basicUdiDi>
    <tradeName>STATUS MULTIFOCAL</tradeName>
    <deviceName>STATUS MULTIFOCAL OPHTHALMIC LENSE</deviceName>
    <manufacturerName>ΜΟΝΟΠΡΟΣΩΠΗ ΑΝΩΝΥΜΗ ΒΙΟΜΗΧΑΝΙΚΗ ΕΜΠΟΡΙΚΗ ΕΤΑΙΡΙΑ ΟΠΤΙΚΩΝ</manufacturerName>
    <manufacturerSrn>GR-MF-000027464</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0210010102</emdnCode>
    <emdnDescription>MULTIFOCAL ORGANIC OPHTHALMIC LENSES (BIFOCAL, TRIFOCAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UO27464STA</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-23T16:57:32.877Z</lastUpdated>
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    <udiDi>06974993063721</udiDi>
    <basicUdiDi>697799306WR-S6459MY</basicUdiDi>
    <tradeName>READING GLASSES</tradeName>
    <deviceName></deviceName>
    <manufacturerName>WENZHOU WONDERFUL EYEWEAR CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000009784</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0210010102</emdnCode>
    <emdnDescription>MULTIFOCAL ORGANIC OPHTHALMIC LENSES (BIFOCAL, TRIFOCAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>697799306WR-S6459MY</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:09:59.954Z</lastUpdated>
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    <udiDi>06974993063769</udiDi>
    <basicUdiDi>697799306WR-S6809N5</basicUdiDi>
    <tradeName>READING GLASSES</tradeName>
    <deviceName></deviceName>
    <manufacturerName>WENZHOU WONDERFUL EYEWEAR CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000009784</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0210010102</emdnCode>
    <emdnDescription>MULTIFOCAL ORGANIC OPHTHALMIC LENSES (BIFOCAL, TRIFOCAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>697799306WR-S6809N5</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:46:14.747Z</lastUpdated>
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    <udiDi>06974993063745</udiDi>
    <basicUdiDi>697799306WR-S5693N3</basicUdiDi>
    <tradeName>READING GLASSES</tradeName>
    <deviceName></deviceName>
    <manufacturerName>WENZHOU WONDERFUL EYEWEAR CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000009784</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0210010102</emdnCode>
    <emdnDescription>MULTIFOCAL ORGANIC OPHTHALMIC LENSES (BIFOCAL, TRIFOCAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>697799306WR-S5693N3</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:46:10.755Z</lastUpdated>
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    <udiDi>06974993063714</udiDi>
    <basicUdiDi>697799306WR-S6787NL</basicUdiDi>
    <tradeName>READING GLASSES</tradeName>
    <deviceName></deviceName>
    <manufacturerName>WENZHOU WONDERFUL EYEWEAR CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000009784</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0210010102</emdnCode>
    <emdnDescription>MULTIFOCAL ORGANIC OPHTHALMIC LENSES (BIFOCAL, TRIFOCAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>697799306WR-S6787NL</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:46:09.944Z</lastUpdated>
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    <udiDi>18404975002608</udiDi>
    <basicUdiDi>081016109PolySFSVOneBJ</basicUdiDi>
    <tradeName>Neochromes ONE Poly HC SFSV Gray 1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Advanced Photochromics LLC</manufacturerName>
    <manufacturerSrn>US-MF-000043049</manufacturerSrn>
    <authorisedRepresentativeName>INDIZEN OPTICAL TECHNOLOGIES S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000042818</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q0210010101</emdnCode>
    <emdnDescription>MONOFOCAL ORGANIC OPHTHALMIC LENSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0265021329</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T04:36:47.709Z</lastUpdated>
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    <udiDi>18404975002615</udiDi>
    <basicUdiDi>081016109PolySFSVOneBJ</basicUdiDi>
    <tradeName>Neochromes ONE Poly HC SFSV Gray 2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Advanced Photochromics LLC</manufacturerName>
    <manufacturerSrn>US-MF-000043049</manufacturerSrn>
    <authorisedRepresentativeName>INDIZEN OPTICAL TECHNOLOGIES S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000042818</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q0210010101</emdnCode>
    <emdnDescription>MONOFOCAL ORGANIC OPHTHALMIC LENSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0265021337</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T04:36:47.685Z</lastUpdated>
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    <udiDi>18404975002622</udiDi>
    <basicUdiDi>081016109PolySFSVOneBJ</basicUdiDi>
    <tradeName>Neochromes ONE Poly HC SFSV Gray 3</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Advanced Photochromics LLC</manufacturerName>
    <manufacturerSrn>US-MF-000043049</manufacturerSrn>
    <authorisedRepresentativeName>INDIZEN OPTICAL TECHNOLOGIES S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000042818</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q0210010101</emdnCode>
    <emdnDescription>MONOFOCAL ORGANIC OPHTHALMIC LENSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0265021345</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T04:36:47.662Z</lastUpdated>
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    <udiDi>18404975002639</udiDi>
    <basicUdiDi>081016109PolySFSVOneBJ</basicUdiDi>
    <tradeName>Neochromes ONE Poly HC SFSV Gray 4</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Advanced Photochromics LLC</manufacturerName>
    <manufacturerSrn>US-MF-000043049</manufacturerSrn>
    <authorisedRepresentativeName>INDIZEN OPTICAL TECHNOLOGIES S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000042818</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q0210010101</emdnCode>
    <emdnDescription>MONOFOCAL ORGANIC OPHTHALMIC LENSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0265021352</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T04:36:47.640Z</lastUpdated>
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    <udiDi>18404975002646</udiDi>
    <basicUdiDi>081016109PolySFSVOneBJ</basicUdiDi>
    <tradeName>Neochromes ONE Poly HC SFSV Gray 5</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Advanced Photochromics LLC</manufacturerName>
    <manufacturerSrn>US-MF-000043049</manufacturerSrn>
    <authorisedRepresentativeName>INDIZEN OPTICAL TECHNOLOGIES S.L.U</authorisedRepresentativeName>
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    <legislation>UNKNOWN</legislation>
    <emdnCode>Q0210010101</emdnCode>
    <emdnDescription>MONOFOCAL ORGANIC OPHTHALMIC LENSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0265021360</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T04:36:47.618Z</lastUpdated>
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    <udiDi>18404975002653</udiDi>
    <basicUdiDi>081016109PolySFSVOneBJ</basicUdiDi>
    <tradeName>Neochromes ONE Poly HC SFSV Gray 6</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Advanced Photochromics LLC</manufacturerName>
    <manufacturerSrn>US-MF-000043049</manufacturerSrn>
    <authorisedRepresentativeName>INDIZEN OPTICAL TECHNOLOGIES S.L.U</authorisedRepresentativeName>
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    <legislation>UNKNOWN</legislation>
    <emdnCode>Q0210010101</emdnCode>
    <emdnDescription>MONOFOCAL ORGANIC OPHTHALMIC LENSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0265021378</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T04:36:47.595Z</lastUpdated>
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    <basicUdiDi>081016109PolySFSVOneBJ</basicUdiDi>
    <tradeName>Neochromes ONE Poly HC SFSV Gray 7</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Advanced Photochromics LLC</manufacturerName>
    <manufacturerSrn>US-MF-000043049</manufacturerSrn>
    <authorisedRepresentativeName>INDIZEN OPTICAL TECHNOLOGIES S.L.U</authorisedRepresentativeName>
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    <legislation>UNKNOWN</legislation>
    <emdnCode>Q0210010101</emdnCode>
    <emdnDescription>MONOFOCAL ORGANIC OPHTHALMIC LENSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0265021386</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T04:36:47.572Z</lastUpdated>
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    <basicUdiDi>081016109PolySFSVOneBJ</basicUdiDi>
    <tradeName>Neochromes ONE Poly HC SFSV Gray 8</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Advanced Photochromics LLC</manufacturerName>
    <manufacturerSrn>US-MF-000043049</manufacturerSrn>
    <authorisedRepresentativeName>INDIZEN OPTICAL TECHNOLOGIES S.L.U</authorisedRepresentativeName>
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    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q0210010101</emdnCode>
    <emdnDescription>MONOFOCAL ORGANIC OPHTHALMIC LENSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0265021394</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T04:36:47.546Z</lastUpdated>
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    <basicUdiDi>081016109PolySFSVOneBJ</basicUdiDi>
    <tradeName>Neochromes ONE Poly HC SFSV Brown 0.50</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Advanced Photochromics LLC</manufacturerName>
    <manufacturerSrn>US-MF-000043049</manufacturerSrn>
    <authorisedRepresentativeName>INDIZEN OPTICAL TECHNOLOGIES S.L.U</authorisedRepresentativeName>
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    <legislation>UNKNOWN</legislation>
    <emdnCode>Q0210010101</emdnCode>
    <emdnDescription>MONOFOCAL ORGANIC OPHTHALMIC LENSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0265021402</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T04:36:47.523Z</lastUpdated>
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    <basicUdiDi>081016109PolySFSVOneBJ</basicUdiDi>
    <tradeName>Neochromes ONE Poly HC SFSV Brown 1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Advanced Photochromics LLC</manufacturerName>
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    <authorisedRepresentativeName>INDIZEN OPTICAL TECHNOLOGIES S.L.U</authorisedRepresentativeName>
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    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q0210010101</emdnCode>
    <emdnDescription>MONOFOCAL ORGANIC OPHTHALMIC LENSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0265021410</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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