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<eudamedExport entity="devices">
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    <udiDi>08033891483937</udiDi>
    <basicUdiDi>803389148CMV19C8</basicUdiDi>
    <tradeName>CMV ELITe MGB® Kit</tradeName>
    <deviceName>CMV ELITe MGB® Kit</deviceName>
    <manufacturerName>ElitechGroup S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000005919</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>RTK015PLD</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-29T08:50:07.471Z</lastUpdated>
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    <udiDi>03573026387662</udiDi>
    <basicUdiDi>357302BUDI000594U6</basicUdiDi>
    <tradeName>CMV R-GENE®</tradeName>
    <deviceName>CMV R-GENE®</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>W0105040205</emdnCode>
    <emdnDescription>CMV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>69-003B</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:50:42.633Z</lastUpdated>
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    <udiDi>08595696303891</udiDi>
    <basicUdiDi>859569630055QS</basicUdiDi>
    <tradeName>GeneProof Cytomegalovirus (CMV) MC PCR Kit</tradeName>
    <deviceName>GeneProof Cytomegalovirus (CMV) MC 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/MC/041</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:33:15.749Z</lastUpdated>
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    <udiDi>15420045514553</udiDi>
    <basicUdiDi>54200455DIAGAPTCMVAP</basicUdiDi>
    <tradeName>Aptima CMV Quant Assay</tradeName>
    <deviceName>Aptima CMV Quant Assay</deviceName>
    <manufacturerName>Hologic</manufacturerName>
    <manufacturerSrn>US-MF-000001646</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040205</emdnCode>
    <emdnDescription>CMV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRD-05074</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:02:43.379Z</lastUpdated>
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  <row>
    <udiDi>00884999050990</udiDi>
    <basicUdiDi>0884999AMN0024WA</basicUdiDi>
    <tradeName>Alinity m</tradeName>
    <deviceName>ALINITY M CMV WB</deviceName>
    <manufacturerName>Abbott Molecular Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017776</manufacturerSrn>
    <authorisedRepresentativeName>Abbott GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009457</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040205</emdnCode>
    <emdnDescription>CMV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09N46-072</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:24:01.035Z</lastUpdated>
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  <row>
    <udiDi>00884999049567</udiDi>
    <basicUdiDi>0884999AMN0946XZ</basicUdiDi>
    <tradeName>Alinity m</tradeName>
    <deviceName>ALINITY M CMV</deviceName>
    <manufacturerName>Abbott Molecular Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017776</manufacturerSrn>
    <authorisedRepresentativeName>Abbott GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009457</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040205</emdnCode>
    <emdnDescription>CMV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09N46-070</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:23:53.027Z</lastUpdated>
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  <row>
    <udiDi>08885013953718</udiDi>
    <basicUdiDi>B-08885013953718</basicUdiDi>
    <tradeName>Sentosa SA CMV Controls Set (8x3)</tradeName>
    <deviceName>Sentosa SA CMV Controls Set (8x3)</deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040205</emdnCode>
    <emdnDescription>CMV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300624</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T14:17:44.712Z</lastUpdated>
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  <row>
    <udiDi>08885013953312</udiDi>
    <basicUdiDi>B-08885013953312</basicUdiDi>
    <tradeName>Sentosa SA CMV Quantitation Controls (4x2)</tradeName>
    <deviceName>Sentosa SA CMV Quantitation Controls (4x2)</deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040205</emdnCode>
    <emdnDescription>CMV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300059</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T14:17:12.289Z</lastUpdated>
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  <row>
    <udiDi>08885013953275</udiDi>
    <basicUdiDi>B-08885013953275</basicUdiDi>
    <tradeName>Sentosa SA CMV Quantitative PCR Test (4x24)</tradeName>
    <deviceName>Sentosa SA CMV Quantitative PCR Test (4x24)</deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040205</emdnCode>
    <emdnDescription>CMV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300114</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T14:17:06.705Z</lastUpdated>
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  <row>
    <udiDi>08698898740799</udiDi>
    <basicUdiDi>B-08698898740799</basicUdiDi>
    <tradeName>Fluorion</tradeName>
    <deviceName>Fluorion CMV QNP 3.0 Real-Time PCR Kit</deviceName>
    <manufacturerName>IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.</manufacturerName>
    <manufacturerSrn>TR-MF-000023054</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040205</emdnCode>
    <emdnDescription>CMV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M0380202</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T12:00:02.037Z</lastUpdated>
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  <row>
    <udiDi>08683548259684</udiDi>
    <basicUdiDi>B-08683548259684</basicUdiDi>
    <tradeName>LyoSens CMV Detection qPCR Kit</tradeName>
    <deviceName>CMV Detection qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040205</emdnCode>
    <emdnDescription>CMV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO42</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:20:58.117Z</lastUpdated>
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  <row>
    <udiDi>08057680910671</udiDi>
    <basicUdiDi>B-08057680910671</basicUdiDi>
    <tradeName>quanty CMVqs</tradeName>
    <deviceName>quanty CMVqs</deviceName>
    <manufacturerName>Clonit srl</manufacturerName>
    <manufacturerSrn>IT-MF-000022196</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040205</emdnCode>
    <emdnDescription>CMV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QS-12</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:35:18.894Z</lastUpdated>
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  <row>
    <udiDi>08057680910077</udiDi>
    <basicUdiDi>B-08057680910077</basicUdiDi>
    <tradeName>quanty CMV</tradeName>
    <deviceName>quanty CMV</deviceName>
    <manufacturerName>Clonit srl</manufacturerName>
    <manufacturerSrn>IT-MF-000022196</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040205</emdnCode>
    <emdnDescription>CMV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RT-12</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:33:23.696Z</lastUpdated>
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  <row>
    <udiDi>08595696303914</udiDi>
    <basicUdiDi>859569630055QS</basicUdiDi>
    <tradeName>GeneProof Cytomegalovirus (CMV) MC PCR Kit</tradeName>
    <deviceName></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/MC/205</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T12:38:26.520Z</lastUpdated>
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  <row>
    <udiDi>06971042229688</udiDi>
    <basicUdiDi>B-06971042229688</basicUdiDi>
    <tradeName>Human Cytomegalovirus (HCMV) Quantitative Real Time PCR Kit</tradeName>
    <deviceName>Human Cytomegalovirus (HCMV) Quantitative Real Time PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040205</emdnCode>
    <emdnDescription>CMV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E-OD-0022-02-96</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:06:53.685Z</lastUpdated>
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    <udiDi>06971042229671</udiDi>
    <basicUdiDi>B-06971042229671</basicUdiDi>
    <tradeName>Human Cytomegalovirus (HCMV) Quantitative Real Time PCR Kit</tradeName>
    <deviceName>Human Cytomegalovirus (HCMV) Quantitative Real Time PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040205</emdnCode>
    <emdnDescription>CMV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E-OD-0022-02-24</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:06:52.902Z</lastUpdated>
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    <udiDi>08906213930085</udiDi>
    <basicUdiDi>89080153043B1215KV</basicUdiDi>
    <tradeName>TRUPCR® CMV QT Kit</tradeName>
    <deviceName>TRUPCR® CMV QT Kit</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</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:03:00.224Z</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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