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<eudamedExport entity="devices">
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    <udiDi>06933260212446</udiDi>
    <basicUdiDi>B-06933260212446</basicUdiDi>
    <tradeName>Virus RNA Collection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01050499</emdnCode>
    <emdnDescription>VIROLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:56:36.535Z</lastUpdated>
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    <udiDi>112009491923</udiDi>
    <basicUdiDi>PP12579SWIFTX.VIRUS30</basicUdiDi>
    <tradeName>112009491923</tradeName>
    <deviceName>SwiftX Virus</deviceName>
    <manufacturerName>Xpedite Diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000020021</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01050499</emdnCode>
    <emdnDescription>VIROLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SXV-50-IVD</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:39:19.434Z</lastUpdated>
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    <udiDi>111917795923</udiDi>
    <basicUdiDi>PP12579SWIFTX.EUROARRAY49</basicUdiDi>
    <tradeName>111917795923</tradeName>
    <deviceName>EUROArray SwiftX-traction</deviceName>
    <manufacturerName>Xpedite Diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000020021</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01050499</emdnCode>
    <emdnDescription>VIROLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SXEA-50-IVD</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:38:21.055Z</lastUpdated>
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    <udiDi>112011809224</udiDi>
    <basicUdiDi>PP12579SWIFTX.VIRUS30</basicUdiDi>
    <tradeName>112011809224</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xpedite Diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000020021</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01050499</emdnCode>
    <emdnDescription>VIROLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBE-078-200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:49:29.156Z</lastUpdated>
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    <udiDi>D-101099</udiDi>
    <basicUdiDi>B-101099</basicUdiDi>
    <tradeName>GA-map® COVID-19 Fecal Test Kit</tradeName>
    <deviceName>GA-map® COVID-19 Fecal Test Kit</deviceName>
    <manufacturerName>Genetic Analysis AS</manufacturerName>
    <manufacturerSrn>NO-MF-000023768</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01050499</emdnCode>
    <emdnDescription>VIROLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1010</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:38:13.628Z</lastUpdated>
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  <row>
    <udiDi>08697962616596</udiDi>
    <basicUdiDi>B-08697962616596</basicUdiDi>
    <tradeName>SOFTEC Human Papillomavirus (HPV) High Risk Panel Qualitative RT-qPCR Detection Kit</tradeName>
    <deviceName>Human Papillomavirus (HPV) High Risk Panel Qualitative RT-qPCR Detection Kit</deviceName>
    <manufacturerName>ZET MEDİKAL TEKSTİL DIŞ TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000046897</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01050499</emdnCode>
    <emdnDescription>VIROLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZT-HPV-01-100</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-09T04:22:05.592Z</lastUpdated>
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  <row>
    <udiDi>08685115805706</udiDi>
    <basicUdiDi>B-08685115805706</basicUdiDi>
    <tradeName>LyoSens Vesicular Rash Genotyping qPCR Kit</tradeName>
    <deviceName>Vesicular Rash Genotyping qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01050499</emdnCode>
    <emdnDescription>VIROLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO61</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:22:49.383Z</lastUpdated>
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    <udiDi>06976202762357</udiDi>
    <basicUdiDi>B-06976202762357</basicUdiDi>
    <tradeName>Adenovirus/RSV Combo Rapid Test</tradeName>
    <deviceName>Adenovirus/RSV Combo Rapid Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01050499</emdnCode>
    <emdnDescription>VIROLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GIADR-722</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:36:55.147Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975412190103</udiDi>
    <basicUdiDi>B-06975412190103</basicUdiDi>
    <tradeName>COVID-19 Nucleic Acid Rapid Test</tradeName>
    <deviceName>Home-Lab</deviceName>
    <manufacturerName>Shanghai GeneSc Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000029293</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01050499</emdnCode>
    <emdnDescription>VIROLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GZ-SC96</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:34:08.871Z</lastUpdated>
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    <udiDi>06975412190097</udiDi>
    <basicUdiDi>B-06975412190097</basicUdiDi>
    <tradeName>COVID-19 Nucleic Acid Rapid Test</tradeName>
    <deviceName>Home-Lab</deviceName>
    <manufacturerName>Shanghai GeneSc Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000029293</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01050499</emdnCode>
    <emdnDescription>VIROLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GZ-SC4</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:34:06.484Z</lastUpdated>
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  <row>
    <udiDi>06975412190080</udiDi>
    <basicUdiDi>B-06975412190080</basicUdiDi>
    <tradeName>COVID-19 Nucleic Acid Rapid Test</tradeName>
    <deviceName>Home-Lab</deviceName>
    <manufacturerName>Shanghai GeneSc Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000029293</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01050499</emdnCode>
    <emdnDescription>VIROLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GZ-SC1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:34:04.880Z</lastUpdated>
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  <row>
    <udiDi>06975412190073</udiDi>
    <basicUdiDi>B-06975412190073</basicUdiDi>
    <tradeName>Novel Coronavirus 2019-nCoV Rapid Detection Kit (LAMP)</tradeName>
    <deviceName>Isothermal Nucleic Acid Amplification Analyzer</deviceName>
    <manufacturerName>Shanghai GeneSc Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000029293</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01050499</emdnCode>
    <emdnDescription>VIROLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GZ-OX96</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:34:04.088Z</lastUpdated>
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    <udiDi>06975412190066</udiDi>
    <basicUdiDi>B-06975412190066</basicUdiDi>
    <tradeName>Novel Coronavirus 2019-nCoV Rapid Detection Kit (LAMP)</tradeName>
    <deviceName>Isothermal Nucleic Acid Amplification Analyzer</deviceName>
    <manufacturerName>Shanghai GeneSc Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000029293</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01050499</emdnCode>
    <emdnDescription>VIROLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GZ-OX48</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:34:02.474Z</lastUpdated>
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    <udiDi>06974689627220</udiDi>
    <basicUdiDi>B-06974689627220</basicUdiDi>
    <tradeName>Monkeypox virus nucleic acid real-time PCR detection kit</tradeName>
    <deviceName>Monkeypox virus nucleic acid real-time PCR detection kit</deviceName>
    <manufacturerName>TargetingOne Technology (Beijing) Corporation</manufacturerName>
    <manufacturerSrn>CN-MF-000028247</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01050499</emdnCode>
    <emdnDescription>VIROLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13802</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:27:37.070Z</lastUpdated>
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    <udiDi>06974689627213</udiDi>
    <basicUdiDi>B-06974689627213</basicUdiDi>
    <tradeName>Monkeypox virus nucleic acid real-time PCR detection kit</tradeName>
    <deviceName>Monkeypox virus nucleic acid real-time PCR detection kit</deviceName>
    <manufacturerName>TargetingOne Technology (Beijing) Corporation</manufacturerName>
    <manufacturerSrn>CN-MF-000028247</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01050499</emdnCode>
    <emdnDescription>VIROLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13801</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:27:36.272Z</lastUpdated>
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    <udiDi>06974689627183</udiDi>
    <basicUdiDi>B-06974689627183</basicUdiDi>
    <tradeName>JCV/BKV nucleic acid digital PCR detection kit</tradeName>
    <deviceName>JCV/BKV nucleic acid digital PCR detection kit</deviceName>
    <manufacturerName>TargetingOne Technology (Beijing) Corporation</manufacturerName>
    <manufacturerSrn>CN-MF-000028247</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01050499</emdnCode>
    <emdnDescription>VIROLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13786-2</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:27:30.666Z</lastUpdated>
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    <udiDi>06974689626346</udiDi>
    <basicUdiDi>B-06974689626346</basicUdiDi>
    <tradeName>JCV/BKV nucleic acid digital PCR detection kit</tradeName>
    <deviceName>JCV/BKV nucleic acid digital PCR detection kit</deviceName>
    <manufacturerName>TargetingOne Technology (Beijing) Corporation</manufacturerName>
    <manufacturerSrn>CN-MF-000028247</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01050499</emdnCode>
    <emdnDescription>VIROLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13786-1</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:24:29.378Z</lastUpdated>
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    <udiDi>06974593880124</udiDi>
    <basicUdiDi>B-06974593880124</basicUdiDi>
    <tradeName>Monkeypox Virus Nuclear Acid Detection Kit (Real Time PCR)</tradeName>
    <deviceName>Monkeypox Virus Nuclear Acid Detection Kit (Real Time PCR)</deviceName>
    <manufacturerName>Shanghai GeneoDx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000029299</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01050499</emdnCode>
    <emdnDescription>VIROLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GZ-MPV100</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:00:57.926Z</lastUpdated>
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    <udiDi>06972221450817</udiDi>
    <basicUdiDi>B-06972221450817</basicUdiDi>
    <tradeName>06972221450817</tradeName>
    <deviceName>Six Respiratory Viruses Nucleic Acid Detection Kit (PCR-Melting Curve Method)</deviceName>
    <manufacturerName>CapitalBio Technology (Chengdu) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027694</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01050499</emdnCode>
    <emdnDescription>VIROLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>96 tests/kit (A)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:44:35.024Z</lastUpdated>
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    <udiDi>06972221450800</udiDi>
    <basicUdiDi>B-06972221450800</basicUdiDi>
    <tradeName>06972221450800</tradeName>
    <deviceName>Six Respiratory Viruses Nucleic Acid Detection Kit (PCR-Melting Curve Method)</deviceName>
    <manufacturerName>CapitalBio Technology (Chengdu) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027694</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01050499</emdnCode>
    <emdnDescription>VIROLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>96 tests/kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:44:33.595Z</lastUpdated>
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