<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08808995360008</udiDi>
    <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>
  </row>
  <row>
    <udiDi>08808995300004</udiDi>
    <basicUdiDi>880899530000NA</basicUdiDi>
    <tradeName>1.56PHOTO</tradeName>
    <deviceName>1.56PHOTO</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>1.56PHOTO</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:44:25.139Z</lastUpdated>
  </row>
  <row>
    <udiDi>08808995260001</udiDi>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
    <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>1.60UV420 BRC</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:44:16.302Z</lastUpdated>
  </row>
  <row>
    <udiDi>08808995100000</udiDi>
    <basicUdiDi>880899510000ML</basicUdiDi>
    <tradeName>1.60UV</tradeName>
    <deviceName>1.60UV</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>1.60</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:44:13.899Z</lastUpdated>
  </row>
  <row>
    <udiDi>08808995060007</udiDi>
    <basicUdiDi>880899506000NK</basicUdiDi>
    <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>
    <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>1.56UV420 BRC</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:44:12.299Z</lastUpdated>
  </row>
  <row>
    <udiDi>08808995040009</udiDi>
    <basicUdiDi>880899504000N5</basicUdiDi>
    <tradeName>1.56</tradeName>
    <deviceName>1.56</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>1.56</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:44:11.494Z</lastUpdated>
  </row>
  <row>
    <udiDi>08808995000003</udiDi>
    <basicUdiDi>880899500000M9</basicUdiDi>
    <tradeName>1.499</tradeName>
    <deviceName>1.499</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>1.499</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:44:09.900Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806387865568</udiDi>
    <basicUdiDi>880638782001KS</basicUdiDi>
    <tradeName>Da:all (P8B1950L-5070)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>META BIOMED CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000009681</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>H0101010299</emdnCode>
    <emdnDescription>SYNTHETIC ABSORBABLE MULTIFILAMENT SUTURES - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:43:23.937Z</lastUpdated>
  </row>
  <row>
    <udiDi>88009887200013</udiDi>
    <basicUdiDi>880098872EMTSR014V</basicUdiDi>
    <tradeName>STAR RUCKUS</tradeName>
    <deviceName>STAR RUCKUS</deviceName>
    <manufacturerName>eMotiv Co., Ltd. MF</manufacturerName>
    <manufacturerSrn>KR-MF-000055708</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V92</emdnCode>
    <emdnDescription>MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EMT-SR01;red</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:40:46.539Z</lastUpdated>
  </row>
  <row>
    <udiDi>18800118000010</udiDi>
    <basicUdiDi>88001180RetiAI68</basicUdiDi>
    <tradeName>18800118000010</tradeName>
    <deviceName>Reti-Eye Reti-CVD</deviceName>
    <manufacturerName>Mediwhale, Inc</manufacturerName>
    <manufacturerSrn>KR-MF-000011626</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z129092</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>IFU-DN-CE-05</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:39:55.239Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806129671105</udiDi>
    <basicUdiDi>880612960001F4</basicUdiDi>
    <tradeName>Scargel Auxilto</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genewel Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000009205</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M04041503</emdnCode>
    <emdnDescription>DRESSINGS IN SOLUTIONS, EMULSIONS, GELS, POWDERS WITH SYNTHETIC COMPONENTS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>MCG12N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:38:32.729Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800337580013</udiDi>
    <basicUdiDi>880033758MEDISTEPMProJG</basicUdiDi>
    <tradeName>MEDISTEP M Pro</tradeName>
    <deviceName>MEDISTEP M Pro</deviceName>
    <manufacturerName>Aitstudio CO., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000051332</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12062592</emdnCode>
    <emdnDescription>KINEMATIC MOTION CAPTURE ANALYSIS SYSTEMS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MEDISTEP</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:37:21.424Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800255550037</udiDi>
    <basicUdiDi>880025555NNS-VB(EU)XE</basicUdiDi>
    <tradeName>vividbrain</tradeName>
    <deviceName>vividbrain – Visual perceptual learning-based medical software</deviceName>
    <manufacturerName>Nunaps Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000047455</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V92</emdnCode>
    <emdnDescription>MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NNS-VB(EU)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:36:22.955Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800115200218</udiDi>
    <basicUdiDi>88001152S-0001U3</basicUdiDi>
    <tradeName>OK-Strips</tradeName>
    <deviceName>OK-Strips, OK-Proxofile</deviceName>
    <manufacturerName>Jaintek Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000045113</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OKS1560/4</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:33:00.250Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800115200010</udiDi>
    <basicUdiDi>88001152H-0001PL</basicUdiDi>
    <tradeName>OK-Handpiece</tradeName>
    <deviceName>Low Speed Dental Handpiece, pneumatic</deviceName>
    <manufacturerName>Jaintek Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000045113</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12110199</emdnCode>
    <emdnDescription>INSTRUMENTS FOR DENTAL TREATMENT UNITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OKH4</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:32:59.447Z</lastUpdated>
  </row>
</eudamedExport>