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    <basicUdiDi>692591270104GW</basicUdiDi>
    <tradeName>iFlash-CMV IgM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040204</emdnCode>
    <emdnDescription>CMV IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C88033M-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:38:13.907Z</lastUpdated>
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    <udiDi>18594036041315</udiDi>
    <basicUdiDi>B-18594036041315</basicUdiDi>
    <tradeName>MONO-VIDITEST anti-CMV IgM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040204</emdnCode>
    <emdnDescription>CMV IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-131-12</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:24:54.497Z</lastUpdated>
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    <udiDi>06942359552165</udiDi>
    <basicUdiDi>697015090000100GM</basicUdiDi>
    <tradeName>CMV IgM CLIA Microparticles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040204</emdnCode>
    <emdnDescription>CMV IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMK0205</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:38:12.121Z</lastUpdated>
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    <udiDi>08594036044029</udiDi>
    <basicUdiDi>B-08594036044029</basicUdiDi>
    <tradeName>ELISA-VIDITEST anti-CMV IgM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040204</emdnCode>
    <emdnDescription>CMV IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OD-402</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:45:27.864Z</lastUpdated>
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    <udiDi>14560189216003</udiDi>
    <basicUdiDi>45601892100010717F</basicUdiDi>
    <tradeName>CL AIA-PACK CMV IgM TEST CUP</tradeName>
    <deviceName>CL AIA-PACK CMV IgM</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040204</emdnCode>
    <emdnDescription>CMV IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0029161</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:57:01.350Z</lastUpdated>
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  <row>
    <udiDi>03573026064396</udiDi>
    <basicUdiDi>357302BUDI000591TY</basicUdiDi>
    <tradeName>VIDAS® CMV IgM</tradeName>
    <deviceName>VIDAS® CMV IgM</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040204</emdnCode>
    <emdnDescription>CMV IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30205</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:32:35.960Z</lastUpdated>
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  <row>
    <udiDi>06970150908812</udiDi>
    <basicUdiDi>697015090000100GM</basicUdiDi>
    <tradeName>CMV IgM CLIA Microparticles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040204</emdnCode>
    <emdnDescription>CMV IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMK0202</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:48:11.179Z</lastUpdated>
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    <udiDi>06903053021128</udiDi>
    <basicUdiDi>69449040004W-CMVIgM****8F</basicUdiDi>
    <tradeName>Cytomegalovirus IgM (CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040204</emdnCode>
    <emdnDescription>CMV IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-012546-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:57.881Z</lastUpdated>
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    <udiDi>06903053021548</udiDi>
    <basicUdiDi>69449040004W-CMVIgM****8F</basicUdiDi>
    <tradeName>Cytomegalovirus IgM (CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040204</emdnCode>
    <emdnDescription>CMV IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-012542-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:57.635Z</lastUpdated>
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  <row>
    <udiDi>06903053021586</udiDi>
    <basicUdiDi>69449040004W-CMVIgM****8F</basicUdiDi>
    <tradeName>Cytomegalovirus IgM (CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040204</emdnCode>
    <emdnDescription>CMV IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-012545-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:57.598Z</lastUpdated>
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  <row>
    <udiDi>14560189216089</udiDi>
    <basicUdiDi>45601892100010717F</basicUdiDi>
    <tradeName>CL AIA-PACK CMV IgM ADJUSTER SET</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040204</emdnCode>
    <emdnDescription>CMV IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0029261</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T17:04:07.593Z</lastUpdated>
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