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    <deviceName>NX Genomic DNA Kit A</deviceName>
    <manufacturerName>Genolution Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000010391</manufacturerSrn>
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    <deviceName>NX-Jr Genomic DNA Kit A</deviceName>
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    <udiDi>08719326569901</udiDi>
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    <tradeName>RealAccurate® Quadruplex Influenza PCR Kit</tradeName>
    <deviceName>RealAccurate® Quadruplex Influenza PCR Kit</deviceName>
    <manufacturerName>PathoFinder B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000002704</manufacturerSrn>
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    <reference>PF0970-R</reference>
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    <tradeName>Freeze-dried Influenza A Virus/Influenza B Virus Nucleic Acid Detection Kit  (Fluorescence PCR)</tradeName>
    <deviceName>Freeze-dried Influenza A Virus/Influenza B Virus Nucleic Acid Detection Kit  (Fluorescence PCR)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-RT176A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:36:45.680Z</lastUpdated>
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    <udiDi>06973843227917</udiDi>
    <basicUdiDi>697384322BSJ04JG</basicUdiDi>
    <tradeName>Influenza A Virus /Influenza B Virus Nucleic Acid Detection Kit (Fluorescence RT-PCR)</tradeName>
    <deviceName>Influenza A Virus /Influenza B Virus Nucleic Acid Detection Kit (Fluorescence RT-PCR)</deviceName>
    <manufacturerName>Hangzhou Bioer Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019512</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSJ04L1</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:02:11.969Z</lastUpdated>
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    <udiDi>06973843227818</udiDi>
    <basicUdiDi>697384322BSJ05JJ</basicUdiDi>
    <tradeName>Respiratory Syncytial Virus Type A / Type B Nucleic Acid Detection Kit (Fluorescent RT- PCR)</tradeName>
    <deviceName>Respiratory Syncytial Virus Type A / Type B Nucleic Acid Detection Kit (Fluorescent RT-PCR)</deviceName>
    <manufacturerName>Hangzhou Bioer Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019512</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040505</emdnCode>
    <emdnDescription>RESPIRATORY SYNCYTIAL VIRUS (RSV) - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSJ05L1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:02:10.386Z</lastUpdated>
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    <udiDi>06973492240206</udiDi>
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    <tradeName>EasyNAT Rapid RSV Assay</tradeName>
    <deviceName>EasyNAT Rapid RSV Assay</deviceName>
    <manufacturerName>Ustar Biotechnologies (Hangzhou) Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014615</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>RESPIRATORY SYNCYTIAL VIRUS (RSV) - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U20208</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:40:19.828Z</lastUpdated>
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    <udiDi>06973492240190</udiDi>
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    <tradeName>EasyNAT Rapid Flu Assay</tradeName>
    <deviceName>EasyNAT Rapid Flu Assay</deviceName>
    <manufacturerName>Ustar Biotechnologies (Hangzhou) Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014615</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U20206</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:40:15.829Z</lastUpdated>
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    <udiDi>15420045509306</udiDi>
    <basicUdiDi>54200455DIAGPFPARAFLURZ</basicUdiDi>
    <tradeName>Panther Fusion Paraflu Assay</tradeName>
    <deviceName>Panther Fusion Paraflu Assay</deviceName>
    <manufacturerName>Hologic</manufacturerName>
    <manufacturerSrn>US-MF-000001646</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040504</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRD-04329</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:06:17.377Z</lastUpdated>
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    <udiDi>15420045509283</udiDi>
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    <tradeName>Panther Fusion Flu A/B/RSV Assay</tradeName>
    <deviceName>Panther Fusion Flu A/B/RSV Assay</deviceName>
    <manufacturerName>Hologic</manufacturerName>
    <manufacturerSrn>US-MF-000001646</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
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    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRD-04328</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:06:10.951Z</lastUpdated>
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    <udiDi>04049095210587</udiDi>
    <basicUdiDi>4049095UN13450000R5</basicUdiDi>
    <tradeName>04049095210587</tradeName>
    <deviceName>RIDA®UNITY Viral Stool Panel IV</deviceName>
    <manufacturerName>R-Biopharm AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
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    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UN1345</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:52:57.234Z</lastUpdated>
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    <basicUdiDi>4049095UN59050000V3</basicUdiDi>
    <tradeName>04049095210150</tradeName>
    <deviceName>RIDA®UNITY RSV &amp; hMPV</deviceName>
    <manufacturerName>R-Biopharm AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
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    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UN5905</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:52:49.725Z</lastUpdated>
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    <basicUdiDi>4049095UN58050000UJ</basicUdiDi>
    <tradeName>04049095210143</tradeName>
    <deviceName>RIDA®UNITY Parainfluenza</deviceName>
    <manufacturerName>R-Biopharm AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040504</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UN5805</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:52:48.932Z</lastUpdated>
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    <udiDi>04049095210082</udiDi>
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    <tradeName>04049095210082</tradeName>
    <deviceName>RIDA®UNITY Norovirus I &amp; II</deviceName>
    <manufacturerName>R-Biopharm AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>NOROVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UN1415</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:52:38.615Z</lastUpdated>
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    <deviceName>RIDA®UNITY Viral Stool Panel II</deviceName>
    <manufacturerName>R-Biopharm AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>UN1325</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:52:36.917Z</lastUpdated>
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    <deviceName>RIDA®UNITY Flu</deviceName>
    <manufacturerName>R-Biopharm AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UN0505</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:52:35.305Z</lastUpdated>
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    <tradeName>FluoroType® BKV HT VER 1.0</tradeName>
    <deviceName>FluoroType® BKV HT VER 1.0</deviceName>
    <manufacturerName>Hain Lifescience GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008606</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>61596HT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:47:38.564Z</lastUpdated>
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    <tradeName>Adenovirus Quantification Kit (96)</tradeName>
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    <manufacturerName>ANT BIYOTEKNOLOJI SANAYI VE TICARET ANONIM SIRKETI</manufacturerName>
    <manufacturerSrn>TR-MF-000052831</manufacturerSrn>
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    <emdnDescription>ADENOVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1010961</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-30T20:29:49.434Z</lastUpdated>
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    <manufacturerName>ANT BIYOTEKNOLOJI SANAYI VE TICARET ANONIM SIRKETI</manufacturerName>
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    <emdnDescription>ADENOVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1010481</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-30T20:29:47.038Z</lastUpdated>
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    <tradeName>TaqPath™ Menu | GeneProof™ Human Herpesvirus 8 (HHV-8) PCR Kit</tradeName>
    <deviceName>GeneProof Human Herpesvirus 8 (HHV-8) 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>W0105040524</emdnCode>
    <emdnDescription>HHV-6,7,8 - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A58434</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:59:46.148Z</lastUpdated>
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