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<eudamedExport entity="devices">
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    <udiDi>16972698600118</udiDi>
    <basicUdiDi>B-16972698600118</basicUdiDi>
    <tradeName>ADV/RSV Antigen Rapid Test Device</tradeName>
    <deviceName>ADV/RSV Antigen Rapid Test Device</deviceName>
    <manufacturerName>Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013495</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P212106</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:50:24.966Z</lastUpdated>
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  <row>
    <udiDi>15065026245349</udiDi>
    <basicUdiDi>B-15065026245349</basicUdiDi>
    <tradeName>TruDerma</tradeName>
    <deviceName>Dermatophyte PCR Test Kit</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070502</emdnCode>
    <emdnDescription>OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TM10002</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:38:04.589Z</lastUpdated>
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  <row>
    <udiDi>D-1214MGG</udiDi>
    <basicUdiDi>B-1214MGG</basicUdiDi>
    <tradeName>mariPOC® Quick combi+ test plate</tradeName>
    <deviceName>mariPOC® Quick combi+ test plate</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1214M</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:53:14.592Z</lastUpdated>
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  <row>
    <udiDi>D-1194MHH</udiDi>
    <basicUdiDi>B-1194MHH</basicUdiDi>
    <tradeName>mariPOC® RTI combi+ test plate</tradeName>
    <deviceName>mariPOC® RTI combi+ test plate</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1194M</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:52:12.921Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1184MHC</udiDi>
    <basicUdiDi>B-1184MHC</basicUdiDi>
    <tradeName>mariPOC® Respi+ test plate</tradeName>
    <deviceName>mariPOC® Respi+ test plate</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1184M</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:52:11.291Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1124MGE</udiDi>
    <basicUdiDi>B-1124MGE</basicUdiDi>
    <tradeName>mariPOC® Pharyn test plate</tradeName>
    <deviceName>mariPOC® Pharyn test plate</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1124M</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:47:57.445Z</lastUpdated>
  </row>
  <row>
    <udiDi>09351179002090</udiDi>
    <basicUdiDi>B-09351179002090</basicUdiDi>
    <tradeName>EasyScreen</tradeName>
    <deviceName>EasyScreen® SARS CoV-2 Detection Kit</deviceName>
    <manufacturerName>Genetic Signatures Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000030901</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>RP012-HT</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:49:42.527Z</lastUpdated>
  </row>
  <row>
    <udiDi>09351179002021</udiDi>
    <basicUdiDi>B-09351179002021</basicUdiDi>
    <tradeName>EasyScreen</tradeName>
    <deviceName>EasyScreen Respiratory Pathogen Detection Kit (RP007)</deviceName>
    <manufacturerName>Genetic Signatures Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000030901</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>RP007-HT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:49:41.637Z</lastUpdated>
  </row>
  <row>
    <udiDi>09351179001505</udiDi>
    <basicUdiDi>B-09351179001505</basicUdiDi>
    <tradeName>EasyScreen</tradeName>
    <deviceName>EasyScreen™ Pan-Enteric Pathogen Detection Kit (PE001)</deviceName>
    <manufacturerName>Genetic Signatures Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000030901</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PE001H-MT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:48:20.973Z</lastUpdated>
  </row>
  <row>
    <udiDi>09351179001475</udiDi>
    <basicUdiDi>B-09351179001475</basicUdiDi>
    <tradeName>EasyScreen</tradeName>
    <deviceName>EasyScreen™ Pan-Enteric Pathogen Detection Kit (PE001)</deviceName>
    <manufacturerName>Genetic Signatures Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000030901</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PE001G-MT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:48:19.445Z</lastUpdated>
  </row>
  <row>
    <udiDi>09351179001420</udiDi>
    <basicUdiDi>B-09351179001420</basicUdiDi>
    <tradeName>EasyScreen</tradeName>
    <deviceName>EasyScreen™ Pan-Enteric Pathogen Detection Kit (PE001)</deviceName>
    <manufacturerName>Genetic Signatures Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000030901</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PE001-MT Panel F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:48:18.640Z</lastUpdated>
  </row>
  <row>
    <udiDi>09351179001383</udiDi>
    <basicUdiDi>B-09351179001383</basicUdiDi>
    <tradeName>EasyScreen</tradeName>
    <deviceName>EasyScreen™ Pan-Enteric Pathogen Detection Kit (PE001)</deviceName>
    <manufacturerName>Genetic Signatures Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000030901</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PE001-MT Panel E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:48:17.778Z</lastUpdated>
  </row>
  <row>
    <udiDi>09351179001345</udiDi>
    <basicUdiDi>B-09351179001345</basicUdiDi>
    <tradeName>EasyScreen</tradeName>
    <deviceName>EasyScreen™ Pan-Enteric Pathogen Detection Kit</deviceName>
    <manufacturerName>Genetic Signatures Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000030901</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PE001-MT Panel D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:48:17.021Z</lastUpdated>
  </row>
  <row>
    <udiDi>09351179001307</udiDi>
    <basicUdiDi>B-09351179001307</basicUdiDi>
    <tradeName>EasyScreen</tradeName>
    <deviceName>EasyScreen ® Pan Enteric Pathogen Detection Kit</deviceName>
    <manufacturerName>Genetic Signatures Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000030901</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PE001-MT Panel C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:48:12.897Z</lastUpdated>
  </row>
  <row>
    <udiDi>09351179001260</udiDi>
    <basicUdiDi>B-09351179001260</basicUdiDi>
    <tradeName>EasyScreen</tradeName>
    <deviceName>EasyScreen ® Pan Enteric Detection Kit PE001 Panel B</deviceName>
    <manufacturerName>Genetic Signatures Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000030901</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PE001-MT Panel B</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:48:12.040Z</lastUpdated>
  </row>
  <row>
    <udiDi>09351179001222</udiDi>
    <basicUdiDi>B-09351179001222</basicUdiDi>
    <tradeName>EasyScreen</tradeName>
    <deviceName>EasyScreen™ Pan-Enteric Pathogen Detection Kit (PE001 - Panel A)</deviceName>
    <manufacturerName>Genetic Signatures Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000030901</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PE001-HT Panel A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:48:11.151Z</lastUpdated>
  </row>
  <row>
    <udiDi>09351179001086</udiDi>
    <basicUdiDi>B-09351179001086</basicUdiDi>
    <tradeName>EasyScreen</tradeName>
    <deviceName>EasyScreen ® Enteric Virus Detection Kit</deviceName>
    <manufacturerName>Genetic Signatures Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000030901</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>EV002-HT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:48:06.442Z</lastUpdated>
  </row>
  <row>
    <udiDi>09351179001024</udiDi>
    <basicUdiDi>B-09351179001024</basicUdiDi>
    <tradeName>EasyScreen</tradeName>
    <deviceName>EasyScreen® Enteric Bacteria Detection Kit</deviceName>
    <manufacturerName>Genetic Signatures Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000030901</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>EB001-HT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:48:04.900Z</lastUpdated>
  </row>
  <row>
    <udiDi>09343044007118</udiDi>
    <basicUdiDi>B-09343044007118</basicUdiDi>
    <tradeName>RIDA®Plex SARS-CoV-2, Influenza and RSV 8 well Step 1</tradeName>
    <deviceName>RIDA®Plex SARS-CoV-2, Influenza and RSV 8 well</deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>R-Biopharm AG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000050025</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80081S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:47:01.865Z</lastUpdated>
  </row>
  <row>
    <udiDi>09343044007101</udiDi>
    <basicUdiDi>B-09343044007101</basicUdiDi>
    <tradeName>RIDA®Plex SARS-CoV-2, Influenza and RSV 8 well Step 2</tradeName>
    <deviceName>RIDA®Plex SARS-CoV-2, Influenza and RSV 8 well</deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>R-Biopharm AG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000050025</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80081P</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:47:01.022Z</lastUpdated>
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</eudamedExport>