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    <basicUdiDi>880974094ACC01EB</basicUdiDi>
    <tradeName>G_PCR Chip Case</tradeName>
    <deviceName>G_PCR Chip Case</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>W02050185</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CTG01-04</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:00:09.960Z</lastUpdated>
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    <udiDi>08809740940117</udiDi>
    <basicUdiDi>880974094LAM306J3</basicUdiDi>
    <tradeName>LOAA-M POWERBOX</tradeName>
    <deviceName>LOAA-M POWERBOX</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>2026-07-03T18:00:08.360Z</lastUpdated>
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    <udiDi>08809740940070</udiDi>
    <basicUdiDi>880974094LAM304HX</basicUdiDi>
    <tradeName>LOAA-M Module</tradeName>
    <deviceName>LOAA-M Module</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>LAM304-01</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:00:07.559Z</lastUpdated>
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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>
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    <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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  <row>
    <udiDi>08809740940087</udiDi>
    <basicUdiDi>B-08809740940087</basicUdiDi>
    <tradeName>Dr. PCR™ BCR-ABL1 Major IS Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OPTOLANE Technologies Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000026042</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DON01-X</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:11:27.427Z</lastUpdated>
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  <row>
    <udiDi>08809740940162</udiDi>
    <basicUdiDi>880974094ACC01EB</basicUdiDi>
    <tradeName>D_PCR Chip Case</tradeName>
    <deviceName></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>W02050185</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CTD01-04</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:11:27.354Z</lastUpdated>
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    <udiDi>08809740940179</udiDi>
    <basicUdiDi>880974094ACC01EB</basicUdiDi>
    <tradeName>Dr. PCR 20K Cartridge -PF</tradeName>
    <deviceName></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>W02050185</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CTR002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:11:27.340Z</lastUpdated>
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