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    <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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    <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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    <udiDi>08680018942633</udiDi>
    <basicUdiDi>868001894PCRHHVCMVQT100AB</basicUdiDi>
    <tradeName>Anatolia Geneworks</tradeName>
    <deviceName>Bosphore CMV Quantification Kit</deviceName>
    <manufacturerName>Anatolia Tani ve Biyoteknoloji Urunleri Arastirma Gelistirme San. ve Tic. A.S.</manufacturerName>
    <manufacturerSrn>TR-MF-000022487</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040205</emdnCode>
    <emdnDescription>CMV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABCMQ2</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T14:06:34.411Z</lastUpdated>
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    <udiDi>08680018942626</udiDi>
    <basicUdiDi>868001894PCRHHVCMVQT100AB</basicUdiDi>
    <tradeName>Anatolia Geneworks</tradeName>
    <deviceName>Bosphore CMV Quantification Kit</deviceName>
    <manufacturerName>Anatolia Tani ve Biyoteknoloji Urunleri Arastirma Gelistirme San. ve Tic. A.S.</manufacturerName>
    <manufacturerSrn>TR-MF-000022487</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040205</emdnCode>
    <emdnDescription>CMV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABCMQ1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T14:06:33.226Z</lastUpdated>
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    <udiDi>08680018941032</udiDi>
    <basicUdiDi>868001894PCRHHVCMVQT100AB</basicUdiDi>
    <tradeName>Anatolia Geneworks</tradeName>
    <deviceName>Bosphore CMV Quantification Kit</deviceName>
    <manufacturerName>Anatolia Tani ve Biyoteknoloji Urunleri Arastirma Gelistirme San. ve Tic. A.S.</manufacturerName>
    <manufacturerSrn>TR-MF-000022487</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040205</emdnCode>
    <emdnDescription>CMV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABCMQ3</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T14:06:24.812Z</lastUpdated>
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    <udiDi>08595696304355</udiDi>
    <basicUdiDi>859569630009QK</basicUdiDi>
    <tradeName>TaqPath™ Menu | GeneProof™ Cytomegalovirus (CMV) PCR Kit</tradeName>
    <deviceName>GeneProof Cytomegalovirus (CMV) PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040205</emdnCode>
    <emdnDescription>CMV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A58428</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:59:38.939Z</lastUpdated>
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    <udiDi>08594161958413</udiDi>
    <basicUdiDi>859569630009QK</basicUdiDi>
    <tradeName>GeneProof Cytomegalovirus (CMV) PCR Kit</tradeName>
    <deviceName>GeneProof Cytomegalovirus (CMV) PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040205</emdnCode>
    <emdnDescription>CMV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMV/GP/100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:56:16.020Z</lastUpdated>
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    <udiDi>08594161958390</udiDi>
    <basicUdiDi>859569630009QK</basicUdiDi>
    <tradeName>GeneProof Cytomegalovirus (CMV) PCR Kit</tradeName>
    <deviceName>GeneProof Cytomegalovirus (CMV) PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040205</emdnCode>
    <emdnDescription>CMV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMV/GP/025</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:56:14.818Z</lastUpdated>
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    <udiDi>06970150908867</udiDi>
    <basicUdiDi>697015090000105GX</basicUdiDi>
    <tradeName>CMV IgG 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>W0105040203</emdnCode>
    <emdnDescription>CMV IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMK0702</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:48:20.776Z</lastUpdated>
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    <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>06903053021289</udiDi>
    <basicUdiDi>69449040004W-CMVIgG****6D</basicUdiDi>
    <tradeName>Cytomegalovirus IgG (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>W0105040203</emdnCode>
    <emdnDescription>CMV IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-012539-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:57.824Z</lastUpdated>
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    <udiDi>06903053021401</udiDi>
    <basicUdiDi>69449040004W-CMVIgG****6D</basicUdiDi>
    <tradeName>Cytomegalovirus IgG (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>W0105040203</emdnCode>
    <emdnDescription>CMV IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-012537-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:57.755Z</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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    <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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    <udiDi>06903053021630</udiDi>
    <basicUdiDi>69449040004W-CMVIgG****6D</basicUdiDi>
    <tradeName>Cytomegalovirus IgG (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>W0105040203</emdnCode>
    <emdnDescription>CMV IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-012536-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:57.559Z</lastUpdated>
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    <udiDi>08908015304187</udiDi>
    <basicUdiDi>89080153043B1215KV</basicUdiDi>
    <tradeName>TRUPCR® CMV QT Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040205</emdnCode>
    <emdnDescription>CMV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B1215/C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T08:20:08.062Z</lastUpdated>
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    <udiDi>06955792731028</udiDi>
    <basicUdiDi>B-06955792731028</basicUdiDi>
    <tradeName>Human Cytomegalovirus DNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)</tradeName>
    <deviceName>Human Cytomegalovirus DNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040205</emdnCode>
    <emdnDescription>CMV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3014E</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:29:42.926Z</lastUpdated>
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    <udiDi>08906213930092</udiDi>
    <basicUdiDi>89080153043B1215KV</basicUdiDi>
    <tradeName>TRUPCR® CMV QT Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040205</emdnCode>
    <emdnDescription>CMV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B1216</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T19:46:07.915Z</lastUpdated>
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    <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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