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    <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>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0210010101</emdnCode>
    <emdnDescription>MONOFOCAL ORGANIC OPHTHALMIC LENSES</emdnDescription>
    <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>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0210010101</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>0265021311</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-30T16:54:07.077Z</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>
    <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>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>
    <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>0265021378</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T04:36:47.595Z</lastUpdated>
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    <udiDi>18404975002660</udiDi>
    <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>
    <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>0265021386</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T04:36:47.572Z</lastUpdated>
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    <udiDi>18404975002677</udiDi>
    <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>
    <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>0265021394</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T04:36:47.546Z</lastUpdated>
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    <udiDi>18404975002684</udiDi>
    <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>
    <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>0265021402</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T04:36:47.523Z</lastUpdated>
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    <udiDi>18404975002691</udiDi>
    <basicUdiDi>081016109PolySFSVOneBJ</basicUdiDi>
    <tradeName>Neochromes ONE Poly HC SFSV Brown 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>0265021410</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T04:36:47.504Z</lastUpdated>
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    <udiDi>18404975002707</udiDi>
    <basicUdiDi>081016109PolySFSVOneBJ</basicUdiDi>
    <tradeName>Neochromes ONE Poly HC SFSV Brown 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>0265021428</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T04:36:47.490Z</lastUpdated>
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    <udiDi>18404975002714</udiDi>
    <basicUdiDi>081016109PolySFSVOneBJ</basicUdiDi>
    <tradeName>Neochromes ONE Poly HC SFSV Brown 3</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>0265021436</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T04:36:47.479Z</lastUpdated>
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    <udiDi>18404975002721</udiDi>
    <basicUdiDi>081016109PolySFSVOneBJ</basicUdiDi>
    <tradeName>Neochromes ONE Poly HC SFSV Brown 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>0265021444</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T04:36:47.463Z</lastUpdated>
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    <udiDi>18404975002738</udiDi>
    <basicUdiDi>081016109PolySFSVOneBJ</basicUdiDi>
    <tradeName>Neochromes ONE Poly HC SFSV Brown 5</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>0265021451</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T04:36:47.435Z</lastUpdated>
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    <udiDi>18404975002745</udiDi>
    <basicUdiDi>081016109PolySFSVOneBJ</basicUdiDi>
    <tradeName>Neochromes ONE Poly HC SFSV Brown 6</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>0265021469</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T04:36:47.412Z</lastUpdated>
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    <udiDi>18404975002752</udiDi>
    <basicUdiDi>081016109PolySFSVOneBJ</basicUdiDi>
    <tradeName>Neochromes ONE Poly HC SFSV Brown 7</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>0265021477</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T04:36:47.390Z</lastUpdated>
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    <udiDi>18404975002769</udiDi>
    <basicUdiDi>081016109PolySFSVOneBJ</basicUdiDi>
    <tradeName>Neochromes ONE Poly HC SFSV Brown 8</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>0265021485</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T04:36:47.368Z</lastUpdated>
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    <udiDi>18404975004442</udiDi>
    <basicUdiDi>081016109150SFSVOneE4</basicUdiDi>
    <tradeName>Neochromes ONE Hard Resin UC 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>0265020446</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T04:36:47.320Z</lastUpdated>
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