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<eudamedExport entity="devices">
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    <udiDi>05061059980038</udiDi>
    <basicUdiDi>B-05061059980038</basicUdiDi>
    <tradeName>05061059980038</tradeName>
    <deviceName>ZENA MAX Respiratory Panel 4 SARS-CoV-2 and Coronavirus (HKU1, NL63, OC43, 229E)</deviceName>
    <manufacturerName>Advanced Molecular Diagnostics Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000043044</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KD146104M-100</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:45:26.464Z</lastUpdated>
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  <row>
    <udiDi>05061059980021</udiDi>
    <basicUdiDi>B-05061059980021</basicUdiDi>
    <tradeName>05061059980021</tradeName>
    <deviceName>ZENA MAX Respiratory Panel 3 SARS-CoV-2, Influenza A&amp;B and H1N1 Real Time PCR Detection Kit</deviceName>
    <manufacturerName>Advanced Molecular Diagnostics Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000043044</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KD146103M-100</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:45:25.673Z</lastUpdated>
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  <row>
    <udiDi>05061059980014</udiDi>
    <basicUdiDi>B-05061059980014</basicUdiDi>
    <tradeName>05061059980014</tradeName>
    <deviceName>ZENA MAX Respiratory Panel 2 SARS-CoV-2, Influenza A &amp; B and RSB A&amp;B Real Time PCR Detection Kit</deviceName>
    <manufacturerName>Advanced Molecular Diagnostics Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000043044</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KD146102M-100</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:45:24.867Z</lastUpdated>
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    <udiDi>05061059980007</udiDi>
    <basicUdiDi>B-05061059980007</basicUdiDi>
    <tradeName>05061059980007</tradeName>
    <deviceName>ZENA MAX Respiratory Panel 1 SARS-CoV-2, Influenza A and B Real Time PCR Detection Kit</deviceName>
    <manufacturerName>Advanced Molecular Diagnostics Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000043044</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KD146101M-100</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:45:24.080Z</lastUpdated>
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  <row>
    <udiDi>05060972700006</udiDi>
    <basicUdiDi>B-05060972700006</basicUdiDi>
    <tradeName>05060972700006</tradeName>
    <deviceName>YouSeq SARS-CoV-2 Multiplex qRT-PCR kit</deviceName>
    <manufacturerName>YouSeq Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000033902</manufacturerSrn>
    <authorisedRepresentativeName>Casus Consulting Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000023507</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>YS-qPX-CVD19-002-CE</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:39:36.387Z</lastUpdated>
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  <row>
    <udiDi>05051716000407</udiDi>
    <basicUdiDi>B-05051716000407</basicUdiDi>
    <tradeName>T-SPOT.CMV</tradeName>
    <deviceName>T-SPOT.CMV</deviceName>
    <manufacturerName>Oxford Immunotec Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004429</manufacturerSrn>
    <authorisedRepresentativeName>Wallac Oy</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FI-AR-000044744</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900299</emdnCode>
    <emdnDescription>INFECTIOUS IMMUNOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMV.400</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-02T12:51:11.348Z</lastUpdated>
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    <udiDi>05051716000193</udiDi>
    <basicUdiDi>B-05051716000193</basicUdiDi>
    <tradeName>T-SPOT.COVID</tradeName>
    <deviceName>T-SPOT.COVID</deviceName>
    <manufacturerName>Oxford Immunotec Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004429</manufacturerSrn>
    <authorisedRepresentativeName>Oxford Immunotec (Ireland) Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003507</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900299</emdnCode>
    <emdnDescription>INFECTIOUS IMMUNOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COV.435/300</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-02T12:51:10.555Z</lastUpdated>
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  <row>
    <udiDi>04987815071110</udiDi>
    <basicUdiDi>B-04987815071110</basicUdiDi>
    <tradeName>Positive Control Flu</tradeName>
    <deviceName>Positive Control Flu</deviceName>
    <manufacturerName>TAUNS Laboratories, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000007041</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105094001</emdnCode>
    <emdnDescription>CONTROLS INFECTIOUS IMMUNOLOGY/NAT - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACPC7111</reference>
    <placedOnMarketCountry>Latvia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:45:53.616Z</lastUpdated>
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  <row>
    <udiDi>04987815016715</udiDi>
    <basicUdiDi>B-04987815016715</basicUdiDi>
    <tradeName>Capilia hMPV Test Plate 10T/Box</tradeName>
    <deviceName>Capilia hMPV Test Plate 10T/Box</deviceName>
    <manufacturerName>TAUNS Laboratories, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000007041</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAHM1671</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:45:52.825Z</lastUpdated>
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  <row>
    <udiDi>04987815016708</udiDi>
    <basicUdiDi>B-04987815016708</basicUdiDi>
    <tradeName>Capilia hMPV 20T/Box</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TAUNS Laboratories, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000007041</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAHM1670</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:43:50.855Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987815015718</udiDi>
    <basicUdiDi>B-04987815015718</basicUdiDi>
    <tradeName>Capilia Mycoplasma 10T/Box</tradeName>
    <deviceName>Capilia Mycoplasma 10T/Box</deviceName>
    <manufacturerName>TAUNS Laboratories, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000007041</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAMP1571</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:43:49.950Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987815011703</udiDi>
    <basicUdiDi>B-04987815011703</basicUdiDi>
    <tradeName>Capilia Strep A 20T/Box</tradeName>
    <deviceName>Capilia Strep A 20T/Box</deviceName>
    <manufacturerName>TAUNS Laboratories, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000007041</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAST1170</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:43:49.151Z</lastUpdated>
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  <row>
    <udiDi>04987815009717</udiDi>
    <basicUdiDi>B-04987815009717</basicUdiDi>
    <tradeName>Capilia RSV Neo Test Plate 10T/Box</tradeName>
    <deviceName>Capilia RSV Neo Test Plate 10T/Box</deviceName>
    <manufacturerName>TAUNS Laboratories, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000007041</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099002</emdnCode>
    <emdnDescription>RSV - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CARS0971</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:43:48.352Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987815009700</udiDi>
    <basicUdiDi>B-04987815009700</basicUdiDi>
    <tradeName>Capilia RSV Neo 20T/Box</tradeName>
    <deviceName>Capilia RSV Neo 20T/Box</deviceName>
    <manufacturerName>TAUNS Laboratories, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000007041</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099002</emdnCode>
    <emdnDescription>RSV - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CARS0970</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:43:47.554Z</lastUpdated>
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    <udiDi>04987815005702</udiDi>
    <basicUdiDi>B-04987815005702</basicUdiDi>
    <tradeName>Capilia Flu Neo 20T/Box</tradeName>
    <deviceName>Capilia Flu Neo 20T/Box</deviceName>
    <manufacturerName>TAUNS Laboratories, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000007041</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAFL0570</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:43:43.549Z</lastUpdated>
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    <udiDi>04987815003715</udiDi>
    <basicUdiDi>B-04987815003715</basicUdiDi>
    <tradeName>Capilia Adeno Neo Test Plate 10T/Box</tradeName>
    <deviceName>Capilia Adeno Neo Test Plate 10T/Box</deviceName>
    <manufacturerName>TAUNS Laboratories, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000007041</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAAD0371</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:43:42.745Z</lastUpdated>
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    <udiDi>04987815003708</udiDi>
    <basicUdiDi>B-04987815003708</basicUdiDi>
    <tradeName>Capilia Adeno Neo 20T/Box</tradeName>
    <deviceName>Capilia Adeno Neo 20T/Box</deviceName>
    <manufacturerName>TAUNS Laboratories, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000007041</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAAD0370</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:43:41.952Z</lastUpdated>
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    <udiDi>04897116730039</udiDi>
    <basicUdiDi>B-04897116730039</basicUdiDi>
    <tradeName>04897116730039</tradeName>
    <deviceName>INDICAID COVID-19 RAPID ANTIGEN TEST</deviceName>
    <manufacturerName>Phase Scientific International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000025791</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2110200</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:17:33.051Z</lastUpdated>
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    <udiDi>04897036920411</udiDi>
    <basicUdiDi>B-04897036920411</basicUdiDi>
    <tradeName>04897036920411</tradeName>
    <deviceName>GenoScreen HPV-HR Plus Screening qPCR Assay</deviceName>
    <manufacturerName>DiagCor Life Science Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000045806</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041002</emdnCode>
    <emdnDescription>SCREENING HIGH-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>92042</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:16:40.958Z</lastUpdated>
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    <udiDi>04897036920404</udiDi>
    <basicUdiDi>B-04897036920404</basicUdiDi>
    <tradeName>04897036920404</tradeName>
    <deviceName>GenoScreen HPV-HR Screening qPCR Assay (Lyophilized)</deviceName>
    <manufacturerName>DiagCor Life Science Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000045806</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041003</emdnCode>
    <emdnDescription>PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>92041</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:16:36.951Z</lastUpdated>
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