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<eudamedExport entity="devices">
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    <udiDi>08809740940124</udiDi>
    <basicUdiDi>8809740943M0069J</basicUdiDi>
    <tradeName>LOAA-M Powerbox System</tradeName>
    <deviceName>LOAA-M Powerbox System</deviceName>
    <manufacturerName>OPTOLANE Technologies Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000026042</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LAM306-01</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:00:06.061Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809740940063</udiDi>
    <basicUdiDi>880974094LAM303HV</basicUdiDi>
    <tradeName>08809740940063</tradeName>
    <deviceName>LOAA-M Console</deviceName>
    <manufacturerName>OPTOLANE Technologies Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000026042</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LAM303-01</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:59:52.297Z</lastUpdated>
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  <row>
    <udiDi>08809740940025</udiDi>
    <basicUdiDi>880974094LAM301HR</basicUdiDi>
    <tradeName>LOAA Analyzer</tradeName>
    <deviceName>LOAA Analyzer</deviceName>
    <manufacturerName>OPTOLANE Technologies Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000026042</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LAM301-01</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:59:48.291Z</lastUpdated>
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    <udiDi>08809537078412</udiDi>
    <basicUdiDi>880953707A20656V</basicUdiDi>
    <tradeName>ExiCycler™ V5 96</tradeName>
    <deviceName>ExiCycler™ V5</deviceName>
    <manufacturerName>BIONEER Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000018672</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-2065-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:59:09.866Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809537078030</udiDi>
    <basicUdiDi>880953707A25001ZB</basicUdiDi>
    <tradeName>ExiStation™ FA 96</tradeName>
    <deviceName>ExiStation™ FA 96/384</deviceName>
    <manufacturerName>BIONEER Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000018672</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-2500-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:59:07.468Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809537070744</udiDi>
    <basicUdiDi>880953707A26006X</basicUdiDi>
    <tradeName>IRON-qPCR™</tradeName>
    <deviceName>IRON-qPCR™</deviceName>
    <manufacturerName>BIONEER Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000018672</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-2600</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:58:49.010Z</lastUpdated>
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  <row>
    <udiDi>08809537070188</udiDi>
    <basicUdiDi>880953707A52507F</basicUdiDi>
    <tradeName>ExiPrep™96 Lite</tradeName>
    <deviceName>ExiPrep™96 Lite</deviceName>
    <manufacturerName>BIONEER Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000018672</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-5250</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:58:46.600Z</lastUpdated>
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  <row>
    <udiDi>08809537070065</udiDi>
    <basicUdiDi>880953707A505075</basicUdiDi>
    <tradeName>ExiPrep™16 Dx</tradeName>
    <deviceName>ExiPrep™16 Dx</deviceName>
    <manufacturerName>BIONEER Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000018672</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-5050</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:58:45.014Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809537070058</udiDi>
    <basicUdiDi>880953707A51507A</basicUdiDi>
    <tradeName>ExiPrep™48 Dx</tradeName>
    <deviceName>ExiPrep™48 Dx</deviceName>
    <manufacturerName>BIONEER Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000018672</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-5150</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:58:44.196Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809537070034</udiDi>
    <basicUdiDi>880953707A20601Z6</basicUdiDi>
    <tradeName>Exicycler™ 96</tradeName>
    <deviceName>Exicycler™ 96</deviceName>
    <manufacturerName>BIONEER Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000018672</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-2060-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:58:42.600Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809054870391</udiDi>
    <basicUdiDi>88090548717188-96VF</basicUdiDi>
    <tradeName>08809054870391</tradeName>
    <deviceName>AutoXT Total gDNA Kit</deviceName>
    <manufacturerName>iNtRON Biotechnology</manufacturerName>
    <manufacturerSrn>KR-MF-000036507</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>17188-96</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:44:37.121Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809054870384</udiDi>
    <basicUdiDi>88090548717188-48V4</basicUdiDi>
    <tradeName>08809054870384</tradeName>
    <deviceName>AutoXT Total gDNA Kit</deviceName>
    <manufacturerName>iNtRON Biotechnology</manufacturerName>
    <manufacturerSrn>KR-MF-000036507</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>17188-48</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:44:35.514Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800204300690</udiDi>
    <basicUdiDi>88002043RADIPCRHC</basicUdiDi>
    <tradeName>08800204300690</tradeName>
    <deviceName>RADI PCR 96 PLUS</deviceName>
    <manufacturerName>KH Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000017883</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KM005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:35:11.635Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800204300096</udiDi>
    <basicUdiDi>88002043RADICHAMP25</basicUdiDi>
    <tradeName>08800204300096</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KH Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000017883</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KM002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:34:55.579Z</lastUpdated>
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    <udiDi>08800151200272</udiDi>
    <basicUdiDi>88001512CL2016Z8</basicUdiDi>
    <tradeName>08800151200272</tradeName>
    <deviceName>CLEO™ AP16</deviceName>
    <manufacturerName>Wizbiosolutions Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000024896</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL2016</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:34:18.735Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800151200241</udiDi>
    <basicUdiDi>88001512CL0001P1SV</basicUdiDi>
    <tradeName>08800151200241</tradeName>
    <deviceName>CLEO™ ONE</deviceName>
    <manufacturerName>Wizbiosolutions Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000024896</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL0001P1</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:34:17.134Z</lastUpdated>
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    <udiDi>08800151200067</udiDi>
    <basicUdiDi>88001512CL0016YS</basicUdiDi>
    <tradeName>08800151200067</tradeName>
    <deviceName>CLEO™ Q16</deviceName>
    <manufacturerName>Wizbiosolutions Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000024896</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL0016</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:34:12.332Z</lastUpdated>
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    <udiDi>08800122900064</udiDi>
    <basicUdiDi>88001229AIM4K2</basicUdiDi>
    <tradeName>isoQuarkM4</tradeName>
    <deviceName>isoQuarkM4</deviceName>
    <manufacturerName>RevoSketch Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000037550</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RS-AIM4-E001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:33:15.442Z</lastUpdated>
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    <udiDi>08800122900019</udiDi>
    <basicUdiDi>88001229ASS7MC</basicUdiDi>
    <tradeName>SS-7010</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RevoSketch Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000037550</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RS-ASS7-E001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:33:14.652Z</lastUpdated>
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    <udiDi>08800122900002</udiDi>
    <basicUdiDi>88001229AIF2J9</basicUdiDi>
    <tradeName>isoQuarkF2</tradeName>
    <deviceName>isoQuarkF2</deviceName>
    <manufacturerName>RevoSketch Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000037550</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RS-AIF2-E001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:33:13.849Z</lastUpdated>
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