<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05055860864168</udiDi>
    <basicUdiDi>50558608fra-cp-mix-fr-sA5</basicUdiDi>
    <tradeName>SG-CP121</tradeName>
    <deviceName>Frames CP mix fullrim sun</deviceName>
    <manufacturerName>Sunoptic International Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000009257</manufacturerSrn>
    <authorisedRepresentativeName>Sunoptic Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000003314</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q02100299</emdnCode>
    <emdnDescription>SPECTACLE FRAMES WITHOUT LENSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SG-CP121</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:18:55.845Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055860863093</udiDi>
    <basicUdiDi>50558608fra-cp-mix-frH4</basicUdiDi>
    <tradeName>CP121</tradeName>
    <deviceName>Frames CP mix fullrim</deviceName>
    <manufacturerName>Sunoptic International Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000009257</manufacturerSrn>
    <authorisedRepresentativeName>Sunoptic Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000003314</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q02100299</emdnCode>
    <emdnDescription>SPECTACLE FRAMES WITHOUT LENSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP121</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:18:54.250Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055860862720</udiDi>
    <basicUdiDi>50558608fra-met-mix-frs2U</basicUdiDi>
    <tradeName>SS-917</tradeName>
    <deviceName>Frames metal mix fullrim sun</deviceName>
    <manufacturerName>Sunoptic International Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000009257</manufacturerSrn>
    <authorisedRepresentativeName>Sunoptic Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000003314</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q02100203</emdnCode>
    <emdnDescription>METAL AND PLASTIC SPECTACLE FRAMES WITHOUT LENSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SS-917</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:18:51.837Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055860842135</udiDi>
    <basicUdiDi>50558608fra-ace-mix-fr9E</basicUdiDi>
    <tradeName>AC1</tradeName>
    <deviceName>Frames acetate mix fullrim</deviceName>
    <manufacturerName>Sunoptic International Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000009257</manufacturerSrn>
    <authorisedRepresentativeName>Sunoptic Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000003314</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q02100299</emdnCode>
    <emdnDescription>SPECTACLE FRAMES WITHOUT LENSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:18:50.231Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055860854732</udiDi>
    <basicUdiDi>50558608rea-pc-blf-frBP</basicUdiDi>
    <tradeName>HBLF730.00</tradeName>
    <deviceName>Reader PC BLF fullrim</deviceName>
    <manufacturerName>Sunoptic International Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000009257</manufacturerSrn>
    <authorisedRepresentativeName>Sunoptic Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000003314</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0210030299</emdnCode>
    <emdnDescription>READY TO WEAR SPECTACLES WITH MINERAL LENSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBLF730.00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:18:49.438Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055860838725</udiDi>
    <basicUdiDi>50558608fra-pla-mix-frT4</basicUdiDi>
    <tradeName>K1</tradeName>
    <deviceName>Frames plastic mix fullrim</deviceName>
    <manufacturerName>Sunoptic International Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000009257</manufacturerSrn>
    <authorisedRepresentativeName>Sunoptic Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000003314</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q02100202</emdnCode>
    <emdnDescription>PLASTIC SPECTACLE FRAMES WITHOUT LENSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:18:48.356Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055860830491</udiDi>
    <basicUdiDi>50558608rea-pc-fr7R</basicUdiDi>
    <tradeName>BLFBOX73C0.00</tradeName>
    <deviceName>Reader PC fullrim</deviceName>
    <manufacturerName>Sunoptic International Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000009257</manufacturerSrn>
    <authorisedRepresentativeName>Sunoptic Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000003314</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0210030199</emdnCode>
    <emdnDescription>READY TO WEAR SPECTACLES WITH ORGANIC LENSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BLFBOX73C0.00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:18:34.160Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055860829730</udiDi>
    <basicUdiDi>50558608rea-met-mixTJ</basicUdiDi>
    <tradeName>BOX681.00</tradeName>
    <deviceName>Reader metal mix</deviceName>
    <manufacturerName>Sunoptic International Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000009257</manufacturerSrn>
    <authorisedRepresentativeName>Sunoptic Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000003314</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0210030101</emdnCode>
    <emdnDescription>READY TO WEAR METAL SPECTACLES WITH ORGANIC LENSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BOX681.00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:18:33.356Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055130035243</udiDi>
    <basicUdiDi>50558608fra-met-mixTP</basicUdiDi>
    <tradeName>510</tradeName>
    <deviceName>Frames Metal Mix</deviceName>
    <manufacturerName>Sunoptic International Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000009257</manufacturerSrn>
    <authorisedRepresentativeName>Sunoptic Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000003314</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q02100201</emdnCode>
    <emdnDescription>METAL SPECTACLE FRAMES WITHOUT LENSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>510</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:10:58.426Z</lastUpdated>
  </row>
  <row>
    <udiDi>05054275151931</udiDi>
    <basicUdiDi>5054275LFLOPTICAL6K</basicUdiDi>
    <tradeName>05054275151931</tradeName>
    <deviceName>OPTICAL FRAMES</deviceName>
    <manufacturerName>Bally Sunglass &amp; Optical Co Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000053846</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q02100299</emdnCode>
    <emdnDescription>SPECTACLE FRAMES WITHOUT LENSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JAC104C1OPT</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:06:47.382Z</lastUpdated>
  </row>
  <row>
    <udiDi>05031720000723</udiDi>
    <basicUdiDi>5031720FTRGLQK</basicUdiDi>
    <tradeName>READING GLASSES/GENEVA</tradeName>
    <deviceName>READING GLASSES</deviceName>
    <manufacturerName>Fortuna Healthcare Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000048072</manufacturerSrn>
    <authorisedRepresentativeName>Fortuna Healthcare (Ireland) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000044547</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0210030103</emdnCode>
    <emdnDescription>READY TO WEAR METAL AND PLASTIC SPECTACLES WITH ORGANIC LENSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FTGENEVA1.50</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:55:05.494Z</lastUpdated>
  </row>
  <row>
    <udiDi>04960682003460</udiDi>
    <basicUdiDi>4960682Pl1.67SvClearZJ</basicUdiDi>
    <tradeName>1.67AS UV</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TOKAI OPTICAL CO., LTD,</manufacturerName>
    <manufacturerSrn>JP-MF-000024672</manufacturerSrn>
    <authorisedRepresentativeName>Tokai Optecs NV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000024178</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0210010101</emdnCode>
    <emdnDescription>MONOFOCAL ORGANIC OPHTHALMIC LENSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:27:48.805Z</lastUpdated>
  </row>
  <row>
    <udiDi>04960682001640</udiDi>
    <basicUdiDi>4960682Pl1.70SvClearW4</basicUdiDi>
    <tradeName>1.76AS UV</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TOKAI OPTICAL CO., LTD,</manufacturerName>
    <manufacturerSrn>JP-MF-000024672</manufacturerSrn>
    <authorisedRepresentativeName>Tokai Optecs NV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000024178</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0210010101</emdnCode>
    <emdnDescription>MONOFOCAL ORGANIC OPHTHALMIC LENSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>n/a</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:27:48.006Z</lastUpdated>
  </row>
  <row>
    <udiDi>04960682001145</udiDi>
    <basicUdiDi>4960682Pl1.50SvClearUN</basicUdiDi>
    <tradeName>1.50</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TOKAI OPTICAL CO., LTD,</manufacturerName>
    <manufacturerSrn>JP-MF-000024672</manufacturerSrn>
    <authorisedRepresentativeName>Tokai Optecs NV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000024178</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0210010101</emdnCode>
    <emdnDescription>MONOFOCAL ORGANIC OPHTHALMIC LENSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:27:44.004Z</lastUpdated>
  </row>
  <row>
    <udiDi>04960682000780</udiDi>
    <basicUdiDi>4960682Pl1.76SvClearZN</basicUdiDi>
    <tradeName>1.76AS UV</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TOKAI OPTICAL CO., LTD,</manufacturerName>
    <manufacturerSrn>JP-MF-000024672</manufacturerSrn>
    <authorisedRepresentativeName>Tokai Optecs NV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000024178</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0210010101</emdnCode>
    <emdnDescription>MONOFOCAL ORGANIC OPHTHALMIC LENSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:27:43.309Z</lastUpdated>
  </row>
  <row>
    <udiDi>04897154190017</udiDi>
    <basicUdiDi>489715419eyewearNG</basicUdiDi>
    <tradeName>04897154190017</tradeName>
    <deviceName>EYEWEAR</deviceName>
    <manufacturerName>ABBA  OPTICAL COMPANY LIMITED</manufacturerName>
    <manufacturerSrn>HK-MF-000052296</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q02100202</emdnCode>
    <emdnDescription>PLASTIC SPECTACLE FRAMES WITHOUT LENSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PLASTIC OPTICAL FRAME</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:22:06.680Z</lastUpdated>
  </row>
  <row>
    <udiDi>04897150200017</udiDi>
    <basicUdiDi>489715020OF0019Z</basicUdiDi>
    <tradeName>04897150200017</tradeName>
    <deviceName>Optical frame</deviceName>
    <manufacturerName>Plus Eyewear Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000049624</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q02100201</emdnCode>
    <emdnDescription>METAL SPECTACLE FRAMES WITHOUT LENSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA-101A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:22:00.272Z</lastUpdated>
  </row>
  <row>
    <udiDi>04550543009825</udiDi>
    <basicUdiDi>4960682Pl1.60SvClearVD</basicUdiDi>
    <tradeName>LTN 1.60</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TOKAI OPTICAL CO., LTD,</manufacturerName>
    <manufacturerSrn>JP-MF-000024672</manufacturerSrn>
    <authorisedRepresentativeName>Tokai Optecs NV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000024178</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0210010101</emdnCode>
    <emdnDescription>MONOFOCAL ORGANIC OPHTHALMIC LENSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:21:21.873Z</lastUpdated>
  </row>
  <row>
    <udiDi>04897134410104</udiDi>
    <basicUdiDi>48971344122100000GB</basicUdiDi>
    <tradeName>04897134410104</tradeName>
    <deviceName>Ophthalmic lenses （1.57 Standard single vision lenses）</deviceName>
    <manufacturerName>HongKong Marvel Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000038403</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0210030199</emdnCode>
    <emdnDescription>READY TO WEAR SPECTACLES WITH ORGANIC LENSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04897134410104</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:18:40.911Z</lastUpdated>
  </row>
  <row>
    <udiDi>04897134410098</udiDi>
    <basicUdiDi>489713441TX007673-02WA</basicUdiDi>
    <tradeName>04897134410098</tradeName>
    <deviceName>Optical Glasses</deviceName>
    <manufacturerName>HongKong Marvel Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000038403</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0210030199</emdnCode>
    <emdnDescription>READY TO WEAR SPECTACLES WITH ORGANIC LENSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04897134410098</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:18:40.124Z</lastUpdated>
  </row>
</eudamedExport>