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    <tradeName>D-697994388Nc005ZHCW</tradeName>
    <deviceName>SARS-CoV-2 Nucleic Acid Detection Kit</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>
    <emdnCode>W0105041199</emdnCode>
    <emdnDescription>OTHER CORONAVIRUS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Nc005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:26:32.104Z</lastUpdated>
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    <udiDi>D-697994388Fa026WK8C</udiDi>
    <basicUdiDi>B-697994388Fa026WK8C</basicUdiDi>
    <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>
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    <emdnCode>W0105041199</emdnCode>
    <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>06974323019664</udiDi>
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    <tradeName>06974323019664</tradeName>
    <deviceName>SARS-CoV-2 Neutralization Antibody Rapid Test Cassette (Lateral Flow Method)</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>W0105041199</emdnCode>
    <emdnDescription>OTHER CORONAVIRUS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CG9081</reference>
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    <lastUpdated>2026-07-06T16:06:22.674Z</lastUpdated>
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    <udiDi>06974323019657</udiDi>
    <basicUdiDi>B-06974323019657</basicUdiDi>
    <tradeName>06974323019657</tradeName>
    <deviceName>SARS-CoV-2 Neutralization Antibody Rapid Test Cassette (Lateral Flow Method)</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>W0105041199</emdnCode>
    <emdnDescription>OTHER CORONAVIRUS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CG9081</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:06:22.626Z</lastUpdated>
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    <udiDi>06974323019640</udiDi>
    <basicUdiDi>B-06974323019640</basicUdiDi>
    <tradeName>06974323019640</tradeName>
    <deviceName>SARS-CoV-2 Neutralization Antibody Rapid Test Cassette (Lateral Flow Method)</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>W0105041199</emdnCode>
    <emdnDescription>OTHER CORONAVIRUS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CG9081</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:06:19.676Z</lastUpdated>
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    <udiDi>06974323019633</udiDi>
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    <tradeName>06974323019633</tradeName>
    <deviceName>SARS-CoV-2 Neutralization Antibody Rapid Test Cassette (Lateral Flow Method)</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>W0105041199</emdnCode>
    <emdnDescription>OTHER CORONAVIRUS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CG9081</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:06:14.683Z</lastUpdated>
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    <udiDi>06974323019626</udiDi>
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    <tradeName>06974323019626</tradeName>
    <deviceName>SARS-CoV-2 Neutralization Antibody Rapid Test Cassette (Lateral Flow Method)</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>W0105041199</emdnCode>
    <emdnDescription>OTHER CORONAVIRUS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CG9081</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:06:13.884Z</lastUpdated>
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    <udiDi>06974323014072</udiDi>
    <basicUdiDi>B-06974323014072</basicUdiDi>
    <tradeName>06974323014072</tradeName>
    <deviceName>SARS-CoV-2 Neutralization Antibody Rapid Test Cassette (FIA)</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>W0105041199</emdnCode>
    <emdnDescription>OTHER CORONAVIRUS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CF6011</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:57:07.840Z</lastUpdated>
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    <udiDi>06974323014065</udiDi>
    <basicUdiDi>B-06974323014065</basicUdiDi>
    <tradeName>06974323014065</tradeName>
    <deviceName>SARS-CoV-2 Neutralization Antibody Rapid Test Cassette (FIA)</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>W0105041199</emdnCode>
    <emdnDescription>OTHER CORONAVIRUS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CF6011</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:57:07.043Z</lastUpdated>
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    <udiDi>06974323014058</udiDi>
    <basicUdiDi>B-06974323014058</basicUdiDi>
    <tradeName>06974323014058</tradeName>
    <deviceName>SARS-CoV-2 Neutralization Antibody Rapid Test Cassette (FIA)</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>W0105041199</emdnCode>
    <emdnDescription>OTHER CORONAVIRUS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CF6011</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:57:06.263Z</lastUpdated>
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    <udiDi>06974323014041</udiDi>
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    <deviceName>SARS-CoV-2 Neutralization Antibody Rapid Test Cassette (FIA)</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>W0105041199</emdnCode>
    <emdnDescription>OTHER CORONAVIRUS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CF6011</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:57:05.464Z</lastUpdated>
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    <udiDi>06974323014034</udiDi>
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    <tradeName>06974323014034</tradeName>
    <deviceName>SARS-CoV-2 Neutralization Antibody Rapid Test Cassette (FIA)</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>W0105041199</emdnCode>
    <emdnDescription>OTHER CORONAVIRUS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CF6011</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:57:01.450Z</lastUpdated>
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    <udiDi>06974323014027</udiDi>
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    <deviceName>SARS-CoV-2 Neutralization Antibody Rapid Test Cassette (FIA)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041199</emdnCode>
    <emdnDescription>OTHER CORONAVIRUS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CF6011</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:57:00.645Z</lastUpdated>
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    <udiDi>06974323014010</udiDi>
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    <tradeName>06974323014010</tradeName>
    <deviceName>SARS-CoV-2 Neutralization Antibody Rapid Test Cassette (FIA)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
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    <emdnDescription>OTHER CORONAVIRUS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CF6011</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:56:59.845Z</lastUpdated>
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    <deviceName>SARS-CoV-2 Neutralization Antibody Rapid Test Cassette (FIA)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:56:59.040Z</lastUpdated>
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    <udiDi>04050598008809</udiDi>
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    <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>
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    <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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    <udiDi>04050598008298</udiDi>
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    <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>
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    <emdnDescription>OTHER CORONAVIRUS REAGENTS</emdnDescription>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>OTHER CORONAVIRUS REAGENTS</emdnDescription>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:47:05.982Z</lastUpdated>
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    <udiDi>04050598008113</udiDi>
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    <tradeName>MutaPlex® SC2 multi gene, PCR</tradeName>
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    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <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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    <tradeName>MutaPlex® SC2 multi gene, PCR</tradeName>
    <deviceName>MutaPlex® SC2 multi gene, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <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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