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    <tradeName>D-697994388Fa026WK8C</tradeName>
    <deviceName>SARS-CoV-2 Nucleic Acid Detection Kit (Fluorescence Screening)</deviceName>
    <manufacturerName>Kangsheng Information Technology (Hangzhou) Co. LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000053775</manufacturerSrn>
    <authorisedRepresentativeName>Crealkraft GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000049943</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>OTHER CORONAVIRUS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Fa026</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:19:44.796Z</lastUpdated>
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    <udiDi>D-697994388Fa005WB77</udiDi>
    <basicUdiDi>B-697994388Fa005WB77</basicUdiDi>
    <tradeName>D-697994388Fa005WB77</tradeName>
    <deviceName>SARS-CoV-2 Nucleic Acid Detection Kit (Fluorescence)</deviceName>
    <manufacturerName>Kangsheng Information Technology (Hangzhou) Co. LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000053775</manufacturerSrn>
    <authorisedRepresentativeName>Crealkraft GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000049943</authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
    <emdnCode>W0105041101</emdnCode>
    <emdnDescription>CORONAVIRUS AG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Fa005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:19:03.651Z</lastUpdated>
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    <udiDi>07332940009526</udiDi>
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    <tradeName>Xpert®</tradeName>
    <deviceName>Xpert® Xpress SARS-CoV-2</deviceName>
    <manufacturerName>Cepheid</manufacturerName>
    <manufacturerSrn>US-MF-000010979</manufacturerSrn>
    <authorisedRepresentativeName>Cepheid AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000048904</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>XPRSARS-COV2-10</reference>
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    <tradeName>Xpert®</tradeName>
    <deviceName>Xpert® Xpress CoV-2 plus</deviceName>
    <manufacturerName>Cepheid</manufacturerName>
    <manufacturerSrn>US-MF-000010979</manufacturerSrn>
    <authorisedRepresentativeName>Cepheid AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000048904</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XP3SARS-COV2-10</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:56:12.192Z</lastUpdated>
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    <udiDi>+ENTIPCOV61110B</udiDi>
    <basicUdiDi>B-+ENTIPCOV61110B</basicUdiDi>
    <tradeName>+ENTIPCOV61110B</tradeName>
    <deviceName>GSD NovaPrime® TSP SARS-CoV-2</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCOV6111</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:16:36.817Z</lastUpdated>
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    <udiDi>+ENTIPCOV61130D</udiDi>
    <basicUdiDi>B-+ENTIPCOV61130D</basicUdiDi>
    <tradeName>+ENTIPCOV61130D</tradeName>
    <deviceName>GSD NovaPrime® TSP SARS-CoV-2</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCOV6113</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:16:35.221Z</lastUpdated>
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    <udiDi>+ENTICVGQ09700B</udiDi>
    <basicUdiDi>B-+ENTICVGQ09700B</basicUdiDi>
    <tradeName>+ENTICVGQ09700B</tradeName>
    <deviceName>GSD NovaLisa SARS-CoV-2 (COVID-19) quantitative IgG</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041103</emdnCode>
    <emdnDescription>CORONAVIRUS IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CVGQ0970</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:10:55.393Z</lastUpdated>
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    <udiDi>+ENTICOVG094006</udiDi>
    <basicUdiDi>B-+ENTICOVG094006</basicUdiDi>
    <tradeName>+ENTICOVG094006</tradeName>
    <deviceName>NovaLisa® SARS-CoV-2 (COVID-19) IgG</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041103</emdnCode>
    <emdnDescription>CORONAVIRUS IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COVG0940</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:10:42.765Z</lastUpdated>
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    <udiDi>+ENTICOVA094000</udiDi>
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    <tradeName>+ENTICOVA094000</tradeName>
    <deviceName>NovaLisa® SARS-CoV-2 (COVID-19) IgA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041105</emdnCode>
    <emdnDescription>CORONAVIRUS IGA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COVA0940</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:10:41.963Z</lastUpdated>
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    <udiDi>+ENTI301774470T</udiDi>
    <basicUdiDi>B-+ENTI301774470T</basicUdiDi>
    <tradeName>+ENTI301774470T</tradeName>
    <deviceName>SARS-CoV-2 (COVID-19) IgG</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041103</emdnCode>
    <emdnDescription>CORONAVIRUS IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30177447</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:06:51.370Z</lastUpdated>
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    <udiDi>+ENTI301774460S</udiDi>
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    <tradeName>+ENTI301774460S</tradeName>
    <deviceName>SARS-CoV-2 (COVID-19) IgA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041105</emdnCode>
    <emdnDescription>CORONAVIRUS IGA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30177446</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:06:50.564Z</lastUpdated>
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    <udiDi>15420045516991</udiDi>
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    <tradeName>Aptima SARS-CoV-2 Assay</tradeName>
    <deviceName>Aptima SARS-CoV-2 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>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRD-07881</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:02:44.983Z</lastUpdated>
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    <udiDi>00884999049192</udiDi>
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    <tradeName>Alinity m</tradeName>
    <deviceName>ALINITY M SARS-COV-2</deviceName>
    <manufacturerName>Abbott Molecular Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017776</manufacturerSrn>
    <authorisedRepresentativeName>Abbott GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009457</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09N78-080</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:23:47.421Z</lastUpdated>
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    <udiDi>80845357043708</udiDi>
    <basicUdiDi>08453570ABT-0014T</basicUdiDi>
    <tradeName>80845357043708</tradeName>
    <deviceName>QC Sets and Panels: Helix Elite™</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[ABT-001] QC Sets and Panels: Helix Elite™ SARS-CoV-2 Verification Panel</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:56:50.844Z</lastUpdated>
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    <deviceName>Helix Elite™ Molecular Standards: Inactivated Standard</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
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    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[HE0066NS] Helix Elite™ Molecular Standards Inactivated SARS-CoV-2 Whole Virus (Swab)</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:53:52.153Z</lastUpdated>
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    <deviceName>Helix Elite™ Molecular Standards: Inactivated Standard</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
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    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
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    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[HE0065N] Helix Elite™ Molecular Standards Inactivated SARS-CoV-2 Whole Virus (Pellet)</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:53:50.000Z</lastUpdated>
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    <tradeName>MAX</tradeName>
    <deviceName>BD Respiratory Viral Panel for BD MAX™ System</deviceName>
    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
    <manufacturerSrn>US-MF-000018910</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007610</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>445373</reference>
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    <manufacturerName>Kangsheng Information Technology (Hangzhou) Co. LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000053775</manufacturerSrn>
    <authorisedRepresentativeName>Crealkraft GmbH</authorisedRepresentativeName>
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    <lastUpdated>2026-07-14T03:08:15.655Z</lastUpdated>
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    <deviceName>SARS-CoV-2 RT-qPCR DETECTION KIT</deviceName>
    <manufacturerName>APPOLON BIOTECK</manufacturerName>
    <manufacturerSrn>FR-MF-000022234</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <tradeName>Singclean®</tradeName>
    <deviceName>COVID-19 IgG Test kit (Colloidal Gold Method)</deviceName>
    <manufacturerName>Hangzhou Singclean Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014098</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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