<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>++M519TEK0175G</udiDi>
    <basicUdiDi>B-++M519TEK0175G</basicUdiDi>
    <tradeName>Ophthalmo Pro</tradeName>
    <deviceName>Hydrophilic Acrylic Intraocular Lens</deviceName>
    <manufacturerName>Tekia, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020955</manufacturerSrn>
    <authorisedRepresentativeName>CALICEOS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000009387</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P030102090202</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC 3000 HD</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:56:17.291Z</lastUpdated>
  </row>
  <row>
    <udiDi>++M519TEK0165E</udiDi>
    <basicUdiDi>B-++M519TEK0165E</basicUdiDi>
    <tradeName>MeyeLens</tradeName>
    <deviceName>Hydrophilic Acrylic Intraocular Lens</deviceName>
    <manufacturerName>Tekia, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020955</manufacturerSrn>
    <authorisedRepresentativeName>CALICEOS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000009387</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P030102090202</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>360</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:56:16.507Z</lastUpdated>
  </row>
  <row>
    <udiDi>++M519TEK01358</udiDi>
    <basicUdiDi>B-++M519TEK01358</basicUdiDi>
    <tradeName>Tek-Lens II</tradeName>
    <deviceName>Hydrophilic Acrylic Intraocular lens</deviceName>
    <manufacturerName>Tekia, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020955</manufacturerSrn>
    <authorisedRepresentativeName>CALICEOS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000009387</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P030102090202</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>618Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:56:10.887Z</lastUpdated>
  </row>
  <row>
    <udiDi>++M519TEK01256</udiDi>
    <basicUdiDi>B-++M519TEK01256</basicUdiDi>
    <tradeName>Tek-Lens II</tradeName>
    <deviceName>Hydrophilic Acrylic Intraocular lens</deviceName>
    <manufacturerName>Tekia, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020955</manufacturerSrn>
    <authorisedRepresentativeName>CALICEOS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000009387</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P030102090202</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>618</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:56:10.093Z</lastUpdated>
  </row>
  <row>
    <udiDi>++M519TEK01154</udiDi>
    <basicUdiDi>B-++M519TEK01154</basicUdiDi>
    <tradeName>Tek-Lens II</tradeName>
    <deviceName>Hydrophilic Acrylic Intraocular lens</deviceName>
    <manufacturerName>Tekia, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020955</manufacturerSrn>
    <authorisedRepresentativeName>CALICEOS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000009387</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P030102090202</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>617Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:56:09.295Z</lastUpdated>
  </row>
  <row>
    <udiDi>++M519TEK0075D</udiDi>
    <basicUdiDi>B-++M519TEK0075D</basicUdiDi>
    <tradeName>Tek-Lens II</tradeName>
    <deviceName>Hydrophilic Acrylic Intraocular lens</deviceName>
    <manufacturerName>Tekia, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020955</manufacturerSrn>
    <authorisedRepresentativeName>CALICEOS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000009387</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P030102090202</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>872Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:54:07.443Z</lastUpdated>
  </row>
  <row>
    <udiDi>++M519TEK01052</udiDi>
    <basicUdiDi>B-++M519TEK01052</basicUdiDi>
    <tradeName>Tek-Lens II</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tekia, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020955</manufacturerSrn>
    <authorisedRepresentativeName>CALICEOS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000009387</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P030102090202</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>617</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:54:06.660Z</lastUpdated>
  </row>
  <row>
    <udiDi>++M519TEK0065B</udiDi>
    <basicUdiDi>B-++M519TEK0065B</basicUdiDi>
    <tradeName>Tek-Lens II</tradeName>
    <deviceName>Hydrophilic Acrylic Intraocular lens</deviceName>
    <manufacturerName>Tekia, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020955</manufacturerSrn>
    <authorisedRepresentativeName>CALICEOS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000009387</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P030102090202</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>872</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:54:03.434Z</lastUpdated>
  </row>
  <row>
    <udiDi>++M519TEK00559</udiDi>
    <basicUdiDi>B-++M519TEK00559</basicUdiDi>
    <tradeName>Tek-Lens II</tradeName>
    <deviceName>Hydrophilic Acrylic Intraocular lens</deviceName>
    <manufacturerName>Tekia, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020955</manufacturerSrn>
    <authorisedRepresentativeName>CALICEOS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000009387</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P030102090202</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>820Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:54:02.634Z</lastUpdated>
  </row>
  <row>
    <udiDi>++M519TEK00457</udiDi>
    <basicUdiDi>B-++M519TEK00457</basicUdiDi>
    <tradeName>Tek-Lens II</tradeName>
    <deviceName>Hydrophilic Acrylic Intraocular Lens</deviceName>
    <manufacturerName>Tekia, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020955</manufacturerSrn>
    <authorisedRepresentativeName>CALICEOS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000009387</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P030102090202</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>820</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:54:01.856Z</lastUpdated>
  </row>
  <row>
    <udiDi>++M519TEK00355</udiDi>
    <basicUdiDi>B-++M519TEK00355</basicUdiDi>
    <tradeName>Tek-Lens II</tradeName>
    <deviceName>Hydrophilic Acrylic Intraocular Lens</deviceName>
    <manufacturerName>Tekia, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020955</manufacturerSrn>
    <authorisedRepresentativeName>CALICEOS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000009387</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P030102090202</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>811Y</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:54:01.117Z</lastUpdated>
  </row>
  <row>
    <udiDi>++M519TEK0014Z</udiDi>
    <basicUdiDi>B-++M519TEK0014Z</basicUdiDi>
    <tradeName>Tek-Lens II</tradeName>
    <deviceName>Hydrophilic Acrylic Intraocular Lenses</deviceName>
    <manufacturerName>Tekia, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020955</manufacturerSrn>
    <authorisedRepresentativeName>CALICEOS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000009387</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P030102090202</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>811</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:53:56.302Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049154000074</udiDi>
    <basicUdiDi>04049154_PC_M2_H2_O2_BU</basicUdiDi>
    <tradeName>Aspira-aA -20.0</tradeName>
    <deviceName>IOLs, aphakic / Family Aspira-aA/Y</deviceName>
    <manufacturerName>HumanOptics Holding AG</manufacturerName>
    <manufacturerSrn>DE-MF-000017892</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P030102090202</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00084400</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:44:54.803Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049154164851</udiDi>
    <basicUdiDi>04049154_PC_M2_H4_O2_CJ</basicUdiDi>
    <tradeName>04049154164851</tradeName>
    <deviceName>IOLs, aphakic / Family Aspira-aXA/Y</deviceName>
    <manufacturerName>HumanOptics Holding AG</manufacturerName>
    <manufacturerSrn>DE-MF-000017892</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P030102090202</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00087900</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:09:08.772Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049154009039</udiDi>
    <basicUdiDi>04049154_PC_M2_H3_O2_C7</basicUdiDi>
    <tradeName>04049154009039</tradeName>
    <deviceName>IOLs, aphakic / Family MC X11 ASP</deviceName>
    <manufacturerName>HumanOptics Holding AG</manufacturerName>
    <manufacturerSrn>DE-MF-000017892</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P030102090202</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00083100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:09:08.596Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-B609B</udiDi>
    <basicUdiDi>B-B609B</basicUdiDi>
    <tradeName>B60 IntraOcular Lens</tradeName>
    <deviceName>Aspheric Single Piece IOL</deviceName>
    <manufacturerName>iVis Technologies S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000016859</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P030102090202</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B60</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T21:00:23.541Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-AM60HD</udiDi>
    <basicUdiDi>B-AM60HD</basicUdiDi>
    <tradeName>AM60 IntraOcular Lens</tradeName>
    <deviceName>Optimized Asphericity Single Piece IOL</deviceName>
    <manufacturerName>iVis Technologies S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000016859</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P030102090202</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM60</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:35:21.412Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-AA60FH</udiDi>
    <basicUdiDi>B-AA60FH</basicUdiDi>
    <tradeName>AA60 IntraOcular Lens</tradeName>
    <deviceName>Optimized Asphericity Single Piece IOL</deviceName>
    <manufacturerName>iVis Technologies S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000016859</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P030102090202</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AA60</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:16:50.691Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974581570396</udiDi>
    <basicUdiDi>B-06974581570396</basicUdiDi>
    <tradeName>06974581570396</tradeName>
    <deviceName>Intraocular Lens</deviceName>
    <manufacturerName>Shenyang Bio Medical Device Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018394</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P030102090202</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>No</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:00:51.519Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974581570389</udiDi>
    <basicUdiDi>B-06974581570389</basicUdiDi>
    <tradeName>06974581570389</tradeName>
    <deviceName>Intraocular Lens</deviceName>
    <manufacturerName>Shenyang Bio Medical Device Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018394</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P030102090202</emdnCode>
    <emdnDescription>IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>No</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:00:50.717Z</lastUpdated>
  </row>
</eudamedExport>