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<eudamedExport entity="devices">
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    <udiDi>06974323012009</udiDi>
    <basicUdiDi>B-06974323012009</basicUdiDi>
    <tradeName>06974323012009</tradeName>
    <deviceName>ARMS-PCR 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>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A9294YH</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:49:13.550Z</lastUpdated>
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  <row>
    <udiDi>06974323011897</udiDi>
    <basicUdiDi>B-06974323011897</basicUdiDi>
    <tradeName>06974323011897</tradeName>
    <deviceName>SARS-CoV-2 Antigen Rapid Test Cassette</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>W0105041101</emdnCode>
    <emdnDescription>CORONAVIRUS AG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G1S-X</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:48:55.141Z</lastUpdated>
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    <udiDi>06974323011880</udiDi>
    <basicUdiDi>B-06974323011880</basicUdiDi>
    <tradeName>06974323011880</tradeName>
    <deviceName>SARS-CoV-2 Antigen Rapid Test Cassette</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>W0105041101</emdnCode>
    <emdnDescription>CORONAVIRUS AG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06974323011880</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:48:54.354Z</lastUpdated>
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    <udiDi>06973315739771</udiDi>
    <basicUdiDi>B-06973315739771</basicUdiDi>
    <tradeName>2019-Novel Coronavirus (2019-nCoV) Triplex RT-qPCR Detection Kit</tradeName>
    <deviceName>2019-Novel Coronavirus (2019-nCoV) Triplex RT-qPCR Detection Kit</deviceName>
    <manufacturerName>Nanjing Vazyme Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031032</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CD302-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:03:10.256Z</lastUpdated>
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  <row>
    <udiDi>06973315737975</udiDi>
    <basicUdiDi>B-06973315737975</basicUdiDi>
    <tradeName>2019-Novel Coronavirus (2019-nCoV) Triplex RT-qPCR Detection Kit</tradeName>
    <deviceName>2019-Novel Coronavirus (2019-nCoV) Triplex RT-qPCR Detection Kit</deviceName>
    <manufacturerName>Nanjing Vazyme Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031032</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CD312-02</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:02:15.097Z</lastUpdated>
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  <row>
    <udiDi>06972221450701</udiDi>
    <basicUdiDi>B-06972221450701</basicUdiDi>
    <tradeName>06972221450701</tradeName>
    <deviceName>Generic name: SARS-CoV-2 Nucleic Acid Detection Kit (Fluorescent PCR Method)</deviceName>
    <manufacturerName>CapitalBio Technology (Chengdu) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027694</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>96 tests/kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:44:29.782Z</lastUpdated>
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    <udiDi>06972221450695</udiDi>
    <basicUdiDi>B-06972221450695</basicUdiDi>
    <tradeName>06972221450695</tradeName>
    <deviceName>Generic name: SARS-CoV-2 Nucleic Acid Detection Kit (Fluorescent PCR Method)</deviceName>
    <manufacturerName>CapitalBio Technology (Chengdu) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027694</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>32 tests/kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:44:29.669Z</lastUpdated>
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  <row>
    <udiDi>06972221450626</udiDi>
    <basicUdiDi>B-06972221450626</basicUdiDi>
    <tradeName>06972221450626</tradeName>
    <deviceName>SARS-CoV-2 Nucleic Acid Detection Kit (Integrated Isothermal Amplification Chip Method)</deviceName>
    <manufacturerName>CapitalBio Technology (Chengdu) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027694</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12 tests/kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:44:27.371Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598013414</udiDi>
    <basicUdiDi>B-04050598013414</basicUdiDi>
    <tradeName>PreventID® SARS-CoV-2 Antigen</tradeName>
    <deviceName>PreventID® SARS-CoV-2 Antigen</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041101</emdnCode>
    <emdnDescription>CORONAVIRUS AG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KST90104GP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:50:16.664Z</lastUpdated>
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  <row>
    <udiDi>04050598008823</udiDi>
    <basicUdiDi>B-04050598008823</basicUdiDi>
    <tradeName>IDK® anti-SARS-CoV-2 IgG ELISA DBS</tradeName>
    <deviceName>IDK® anti-SARS-CoV-2 IgG ELISA DBS</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041103</emdnCode>
    <emdnDescription>CORONAVIRUS IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K5004DBS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:47:53.280Z</lastUpdated>
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  <row>
    <udiDi>04050598008809</udiDi>
    <basicUdiDi>B-04050598008809</basicUdiDi>
    <tradeName>MutaPlex® CoV-2 MUT 3, PCR</tradeName>
    <deviceName>MutaPlex® CoV-2 MUT 3, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041199</emdnCode>
    <emdnDescription>OTHER CORONAVIRUS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG1933-384</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:47:52.476Z</lastUpdated>
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  <row>
    <udiDi>04050598008304</udiDi>
    <basicUdiDi>B-04050598008304</basicUdiDi>
    <tradeName>MutaPlex® Coronavirus 4G, PCR</tradeName>
    <deviceName>MutaPlex® Coronavirus 4G, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG193696</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:47:07.588Z</lastUpdated>
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  <row>
    <udiDi>04050598008298</udiDi>
    <basicUdiDi>B-04050598008298</basicUdiDi>
    <tradeName>MutaPlex® Coronavirus 4G, PCR</tradeName>
    <deviceName>MutaPlex® Coronavirus 4G, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041199</emdnCode>
    <emdnDescription>OTHER CORONAVIRUS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG1936-768</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:47:06.784Z</lastUpdated>
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  <row>
    <udiDi>04050598008281</udiDi>
    <basicUdiDi>B-04050598008281</basicUdiDi>
    <tradeName>MutaPlex® Coronavirus 4G, PCR</tradeName>
    <deviceName>MutaPlex® Coronavirus 4G, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041199</emdnCode>
    <emdnDescription>OTHER CORONAVIRUS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG1936-384</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:47:05.982Z</lastUpdated>
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  <row>
    <udiDi>04050598008182</udiDi>
    <basicUdiDi>B-04050598008182</basicUdiDi>
    <tradeName>MutaPlex® CoV-2 MUT 2, PCR</tradeName>
    <deviceName>MutaPlex® CoV-2 MUT 2, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG193296</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:46:59.584Z</lastUpdated>
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  <row>
    <udiDi>04050598008175</udiDi>
    <basicUdiDi>B-04050598008175</basicUdiDi>
    <tradeName>MutaPlex® CoV-2 MUT 3, PCR</tradeName>
    <deviceName>MutaPlex® CoV-2 MUT 3, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG193396</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:46:58.786Z</lastUpdated>
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    <udiDi>04050598008113</udiDi>
    <basicUdiDi>B-04050598008113</basicUdiDi>
    <tradeName>MutaPlex® SC2 multi gene, PCR</tradeName>
    <deviceName>MutaPlex® SC2 multi gene, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041199</emdnCode>
    <emdnDescription>OTHER CORONAVIRUS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG1930-768</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:46:53.990Z</lastUpdated>
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    <udiDi>04050598008106</udiDi>
    <basicUdiDi>B-04050598008106</basicUdiDi>
    <tradeName>MutaPlex® SC2 multi gene, PCR</tradeName>
    <deviceName>MutaPlex® SC2 multi gene, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041199</emdnCode>
    <emdnDescription>OTHER CORONAVIRUS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG1930-384</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:46:53.177Z</lastUpdated>
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    <udiDi>04050598008069</udiDi>
    <basicUdiDi>B-04050598008069</basicUdiDi>
    <tradeName>MutaPlex® SC2 multi gene, PCR</tradeName>
    <deviceName>MutaPlex® SC2 multi gene, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041199</emdnCode>
    <emdnDescription>OTHER CORONAVIRUS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG193096</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:46:52.377Z</lastUpdated>
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  <row>
    <udiDi>04050598007987</udiDi>
    <basicUdiDi>B-04050598007987</basicUdiDi>
    <tradeName>MutaPlex® CoV-2 MUT, PCR</tradeName>
    <deviceName>MutaPlex® CoV-2 MUT, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG193196</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:46:45.967Z</lastUpdated>
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