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    <deviceName>SARS-CoV-2 Nucleic Acid Test Kit (PCR-Fluorescent Probe Method)</deviceName>
    <manufacturerName>RocGene (Xuzhou) Technology Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000024511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>10210121B</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:44:23.375Z</lastUpdated>
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    <basicUdiDi>B-06974795550481</basicUdiDi>
    <tradeName>06974795550481</tradeName>
    <deviceName>SARS-CoV-2 Nucleic Acid Test Kit (PCR-Fluorescent Probe Method)</deviceName>
    <manufacturerName>RocGene (Xuzhou) Technology Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000024511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <tradeName>Novel Coronavirus (SARS-CoV-2) Nucleic Acid Detection Kit (Fluorescent RT-MIRA)</tradeName>
    <deviceName>Novel Coronavirus (SARS-CoV-2) Nucleic Acid Detection Kit (Fluorescent RT-MIRA)</deviceName>
    <manufacturerName>Shanghai BioGerm Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018164</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
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    <tradeName>Novel Coronavirus (SARS-CoV-2) Nucleic Acid Detection Kit (Fluorescent RT-MIRA)</tradeName>
    <deviceName>Novel Coronavirus (SARS-CoV-2) Nucleic Acid Detection Kit (Fluorescent RT-MIRA)</deviceName>
    <manufacturerName>Shanghai BioGerm Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018164</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-FZ-022-24-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:23:06.061Z</lastUpdated>
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    <udiDi>06974677690281</udiDi>
    <basicUdiDi>B-06974677690281</basicUdiDi>
    <tradeName>Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (PCR-Fluorescence Probing)</tradeName>
    <deviceName>Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Shanghai BioGerm Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018164</manufacturerSrn>
    <authorisedRepresentativeName>PureMDR GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007923</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZC-HX-201-3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:22:00.460Z</lastUpdated>
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    <udiDi>06974677690274</udiDi>
    <basicUdiDi>B-06974677690274</basicUdiDi>
    <tradeName>Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (PCR-Fluorescence Probing)</tradeName>
    <deviceName>Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Shanghai BioGerm Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018164</manufacturerSrn>
    <authorisedRepresentativeName>PureMDR GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:21:56.967Z</lastUpdated>
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    <deviceName>Duplex Real-Time PCR Detection Kit for SARS-CoV-2 ORF1ab/N</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
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    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A7712RCFDC-48T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:52:28.190Z</lastUpdated>
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    <tradeName>06974323013044</tradeName>
    <deviceName>Duplex Real-Time PCR Detection Kit for SARS-CoV-2 ORF1ab/N</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A7712RCFDC-24T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:52:27.389Z</lastUpdated>
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    <udiDi>06974323013037</udiDi>
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    <tradeName>06974323013037</tradeName>
    <deviceName>Duplex Real-Time PCR Detection Kit for SARS-CoV-2 ORF1ab/N</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A6382FDC-48T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:52:26.599Z</lastUpdated>
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    <tradeName>06974323013020</tradeName>
    <deviceName>Duplex Real-Time PCR Detection Kit for SARS-CoV-2 ORF1ab/N</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A6382FDC-24T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:52:25.803Z</lastUpdated>
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    <udiDi>06974323012894</udiDi>
    <basicUdiDi>B-06974323012894</basicUdiDi>
    <tradeName>06974323012894</tradeName>
    <deviceName>Multiple Real-Time PCR Kit for Detection of 2019-nCoV</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ID019</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:52:08.184Z</lastUpdated>
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    <udiDi>06974323012887</udiDi>
    <basicUdiDi>B-06974323012887</basicUdiDi>
    <tradeName>06974323012887</tradeName>
    <deviceName>Multiple Real-Time PCR Kit for Detection of 2019-nCoV</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ID019</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:52:02.893Z</lastUpdated>
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    <udiDi>06974323012740</udiDi>
    <basicUdiDi>B-06974323012740</basicUdiDi>
    <tradeName>06974323012740</tradeName>
    <deviceName>Duplex Real-Time PCR Kit for Rapid Detection of 2019-nCoV ORF1ab/N gene</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ID009</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:51:29.911Z</lastUpdated>
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    <udiDi>06974323012610</udiDi>
    <basicUdiDi>B-06974323012610</basicUdiDi>
    <tradeName>06974323012610</tradeName>
    <deviceName>ARMS-PCR Diagnostic Detection Kit for 2019-nCoV HV69-70del and N501Y mutation</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
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    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A9294YH</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:51:08.334Z</lastUpdated>
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    <basicUdiDi>B-06974323012603</basicUdiDi>
    <tradeName>06974323012603</tradeName>
    <deviceName>ARMS-PCR Diagnostic Detection Kit for 2019-nCoV HV69-70del and N501Y mutation</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
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    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:51:06.704Z</lastUpdated>
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    <tradeName>06974323012375</tradeName>
    <deviceName>Multiple Real-Time PCR Kit for Detection of 2019-nCoV</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
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    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D1723YH-50T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:50:14.456Z</lastUpdated>
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    <deviceName>Multiple Real-Time PCR Kit for Detection of 2019-nCoV</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:50:12.858Z</lastUpdated>
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    <deviceName>Multiple Real-Time PCR Kit for Detection of 2019-nCoV</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
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    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:50:10.456Z</lastUpdated>
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    <deviceName>Multiple Real-Time PCR Kit for Detection of 2019-nCoV</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
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    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A7793YF-100T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:50:08.848Z</lastUpdated>
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    <deviceName>Multiple Real-Time PCR Kit for Detection of 2019-nCoV</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
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    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A7793YF-50T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
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