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    <basicUdiDi>859569630005QB</basicUdiDi>
    <tradeName>TaqPath™ Menu | GeneProof™ Human Herpesvirus 6/7 (HHV-6/7) PCR Kit</tradeName>
    <deviceName>GeneProof Human Herpesvirus 6/7 (HHV-6/7) 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>A58433</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:59:40.153Z</lastUpdated>
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    <udiDi>08595696300197</udiDi>
    <basicUdiDi>859569630006QD</basicUdiDi>
    <tradeName>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>HHV8/GP/100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:58:41.323Z</lastUpdated>
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    <udiDi>08595696300180</udiDi>
    <basicUdiDi>859569630006QD</basicUdiDi>
    <tradeName>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>HHV8/GP/025</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:58:40.110Z</lastUpdated>
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    <udiDi>08595696300166</udiDi>
    <basicUdiDi>859569630005QB</basicUdiDi>
    <tradeName>GeneProof Human Herpesvirus 6/7 (HHV-6/7) PCR Kit</tradeName>
    <deviceName>GeneProof Human Herpesvirus 6/7 (HHV-6/7) 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>HHV/GP/100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:58:38.915Z</lastUpdated>
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    <udiDi>08595696300159</udiDi>
    <basicUdiDi>859569630005QB</basicUdiDi>
    <tradeName>GeneProof Human Herpesvirus 6/7 (HHV-6/7) PCR Kit</tradeName>
    <deviceName>GeneProof Human Herpesvirus 6/7 (HHV-6/7) 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>HHV/GP/025</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:58:32.897Z</lastUpdated>
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    <udiDi>08594161959304</udiDi>
    <basicUdiDi>859569630028QP</basicUdiDi>
    <tradeName>GeneProof JC Virus (JCV) PCR Kit</tradeName>
    <deviceName>GeneProof JC Virus (JCV) 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>W0105040523</emdnCode>
    <emdnDescription>JC VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JCV/GP/100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:56:28.032Z</lastUpdated>
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    <udiDi>08594161959281</udiDi>
    <basicUdiDi>859569630028QP</basicUdiDi>
    <tradeName>GeneProof JC Virus (JCV) PCR Kit</tradeName>
    <deviceName>GeneProof JC Virus (JCV) 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>W0105040523</emdnCode>
    <emdnDescription>JC VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JCV/GP/025</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:56:26.813Z</lastUpdated>
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    <udiDi>08594161959267</udiDi>
    <basicUdiDi>859569630027QM</basicUdiDi>
    <tradeName>GeneProof BK Virus (BKV) PCR Kit</tradeName>
    <deviceName>GeneProof BK Virus (BKV) 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>W0105040522</emdnCode>
    <emdnDescription>BK VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BKV/GP/100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:56:25.625Z</lastUpdated>
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    <udiDi>08594161959243</udiDi>
    <basicUdiDi>859569630027QM</basicUdiDi>
    <tradeName>GeneProof BK Virus (BKV) PCR Kit</tradeName>
    <deviceName>GeneProof BK Virus (BKV) 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>W0105040522</emdnCode>
    <emdnDescription>BK VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BKV/GP/025</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:56:24.415Z</lastUpdated>
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    <udiDi>08435440228905</udiDi>
    <basicUdiDi>84354402_MDXIMMUN_HHV75</basicUdiDi>
    <tradeName>08435440228905</tradeName>
    <deviceName>VIASURE Human Herpes Virus 6, 7 &amp; 8 Real Time PCR Detection Kit</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</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>VS-HHV112LE</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:31:23.061Z</lastUpdated>
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    <udiDi>08435440213413</udiDi>
    <basicUdiDi>84354402_MDXIMMUN_HHV75</basicUdiDi>
    <tradeName>08435440213413</tradeName>
    <deviceName>VIASURE Human Herpes Virus 6, 7 &amp; 8 Real Time PCR Detection Kit</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</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>VS-HHV106HE</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:31:21.863Z</lastUpdated>
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    <udiDi>08435440208761</udiDi>
    <basicUdiDi>84354402_MDXIMMUN_HHV75</basicUdiDi>
    <tradeName>08435440208761</tradeName>
    <deviceName>VIASURE Human Herpes Virus 6, 7 &amp; 8 Real Time PCR Detection Kit</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</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>VS-HHV106L</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:31:20.670Z</lastUpdated>
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    <udiDi>06974677692544</udiDi>
    <basicUdiDi>6974677692537K9</basicUdiDi>
    <tradeName>Monkeypox Virus Nucleic Acid Detection Kit (PCR-Fluorescence Probing)</tradeName>
    <deviceName>Monkeypox Virus Nucleic Acid Detection Kit (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Shanghai BioGerm Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018164</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-FZ-064-50-CE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:14:03.241Z</lastUpdated>
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    <udiDi>06974677692537</udiDi>
    <basicUdiDi>6974677692537K9</basicUdiDi>
    <tradeName>Monkeypox Virus Nucleic Acid Detection Kit (PCR-Fluorescence Probing)</tradeName>
    <deviceName>Monkeypox Virus Nucleic Acid Detection Kit (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Shanghai BioGerm Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018164</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-FZ-064-25-CE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:14:02.054Z</lastUpdated>
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    <udiDi>06970895479509</udiDi>
    <basicUdiDi>B-06970895479509</basicUdiDi>
    <tradeName>06970895479509</tradeName>
    <deviceName>Monkeypox Virus Nucleic Acid Detection Kit (Fluorescent Probe-based Real-time PCR Assay)</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040532</emdnCode>
    <emdnDescription>MONKEYPOX VIRUS / MPOX - NA REAGENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R60101T2050</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:00:30.709Z</lastUpdated>
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    <udiDi>06970895479011</udiDi>
    <basicUdiDi>B-06970895479011</basicUdiDi>
    <tradeName>06970895479011</tradeName>
    <deviceName>Dengue virus nucleic acid test kit (Fluorescent Probe-based Real-time PCR Assay)</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040511</emdnCode>
    <emdnDescription>DENGUE VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M092T025B0C0</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:00:23.609Z</lastUpdated>
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    <udiDi>06970895479004</udiDi>
    <basicUdiDi>B-06970895479004</basicUdiDi>
    <tradeName>06970895479004</tradeName>
    <deviceName>Dengue virus nucleic acid test kit (Fluorescent Probe-based real-time PCR assay)</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040511</emdnCode>
    <emdnDescription>DENGUE VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M092T050B0C0</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:00:21.107Z</lastUpdated>
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    <udiDi>06970895477130</udiDi>
    <basicUdiDi>B-06970895477130</basicUdiDi>
    <tradeName>06970895477130</tradeName>
    <deviceName>EV71, CA16 and other enterovirual nucleic acid test kit (Fluorescent Probe-based real-time PCR assay)</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040502</emdnCode>
    <emdnDescription>ENTEROVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E011T100B0C1</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:58:17.436Z</lastUpdated>
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    <udiDi>06970895477123</udiDi>
    <basicUdiDi>B-06970895477123</basicUdiDi>
    <tradeName>06970895477123</tradeName>
    <deviceName>EV71, CA16 and Other Enteroviral Nucleic Acid Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040502</emdnCode>
    <emdnDescription>ENTEROVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E011T096B0C1</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:58:16.247Z</lastUpdated>
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    <udiDi>06970895477116</udiDi>
    <basicUdiDi>B-06970895477116</basicUdiDi>
    <tradeName>06970895477116</tradeName>
    <deviceName>EV71, CA16 and other enterovirual nucleic acid test kit (Fluorescent Probe-based real-time PCR assay)</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040502</emdnCode>
    <emdnDescription>ENTEROVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E011T050B0C1</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:58:09.045Z</lastUpdated>
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