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<eudamedExport entity="devices">
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    <udiDi>03532670102625</udiDi>
    <basicUdiDi>B-03532670102625</basicUdiDi>
    <tradeName>BIOSYNEX AMPLIQUICK Respiratory Duplex</tradeName>
    <deviceName>BIOSYNEX AMPLIQUICK Respiratory duplex</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000014073</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3150076_SEC01</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:38:04.254Z</lastUpdated>
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  <row>
    <udiDi>00850027856612</udiDi>
    <basicUdiDi>B-00850027856612</basicUdiDi>
    <tradeName>HVRe Influenza/RSV/SARS-CoV-2</tradeName>
    <deviceName>Fluxergy HVRe Influenza/RSV/ SARS-CoV-2</deviceName>
    <manufacturerName>Fluxergy Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010833</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070399</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>8032</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:00:47.162Z</lastUpdated>
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  <row>
    <udiDi>00850027856605</udiDi>
    <basicUdiDi>B-00850027856605</basicUdiDi>
    <tradeName>HVRe Influenza/RSV/SARS-CoV-2</tradeName>
    <deviceName>Fluxergy HVRe Influenza/RSV/ SARS-CoV-2</deviceName>
    <manufacturerName>Fluxergy Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010833</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070399</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>8029</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:00:43.139Z</lastUpdated>
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  <row>
    <udiDi>D-000041242SI003-254C</udiDi>
    <basicUdiDi>B-000041242SI003-254C</basicUdiDi>
    <tradeName>D-000041242SI003-254C</tradeName>
    <deviceName>SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test (Nasopharyngeal Swab)</deviceName>
    <manufacturerName>Ningbo BESTest Bio-technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041242</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070399</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SI003-25</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:00:50.157Z</lastUpdated>
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  <row>
    <udiDi>D-000041242SI003-0546</udiDi>
    <basicUdiDi>B-000041242SI003-0546</basicUdiDi>
    <tradeName>D-000041242SI003-0546</tradeName>
    <deviceName>SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test (Nasopharyngeal Swab)</deviceName>
    <manufacturerName>Ningbo BESTest Bio-technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041242</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070399</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SI003-05</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:00:49.355Z</lastUpdated>
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  <row>
    <udiDi>D-000041242SI003-013W</udiDi>
    <basicUdiDi>B-000041242SI003-013W</basicUdiDi>
    <tradeName>D-000041242SI003-013W</tradeName>
    <deviceName>SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test (Nasopharyngeal Swab)</deviceName>
    <manufacturerName>Ningbo BESTest Bio-technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041242</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070399</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SI003-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:00:47.753Z</lastUpdated>
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  <row>
    <udiDi>D-000012807191072QE</udiDi>
    <basicUdiDi>B-000012807191072QE</basicUdiDi>
    <tradeName>Influenza A/B Antigen Detection Kit (Immunochromatography)</tradeName>
    <deviceName>Influenza A/B Antigen Detection Kit (Immunochromatography)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070399</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-RT130</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:59:49.264Z</lastUpdated>
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  <row>
    <udiDi>D-0000128071570B4RE</udiDi>
    <basicUdiDi>B-0000128071570B4RE</basicUdiDi>
    <tradeName>Dengue Virus, Zika Virus and Chikungunya Virus Multiplex Nucleic Acid Detection Kit (Fluorescence PCR)</tradeName>
    <deviceName>Dengue Virus, Zika Virus and Chikungunya Virus Multiplex Nucleic Acid Detection Kit (Fluorescence PCR)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070399</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-FE040</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:58:39.560Z</lastUpdated>
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  <row>
    <udiDi>09352224001365</udiDi>
    <basicUdiDi>9352224017031BNA</basicUdiDi>
    <tradeName>PlexPCR Flu/RSV/SARS-CoV-2</tradeName>
    <deviceName>PlexPCR Flu/RSV/SARS-CoV-2</deviceName>
    <manufacturerName>SpeeDx Pty. Ltd.</manufacturerName>
    <manufacturerSrn>AU-MF-000016649</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1703192</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:07:18.378Z</lastUpdated>
  </row>
  <row>
    <udiDi>09352224000108</udiDi>
    <basicUdiDi>9352224012010WA</basicUdiDi>
    <tradeName>PlexPCR RespiVirus (610)</tradeName>
    <deviceName>PlexPCR RespiVirus</deviceName>
    <manufacturerName>SpeeDx Pty. Ltd.</manufacturerName>
    <manufacturerSrn>AU-MF-000016649</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070304</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1201001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:07:15.971Z</lastUpdated>
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  <row>
    <udiDi>08908015304958</udiDi>
    <basicUdiDi>89080153043B1271L7</basicUdiDi>
    <tradeName>TRUPCR® TORCH Panel Kit</tradeName>
    <deviceName>TRUPCR® TORCH Panel Kit</deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B1271/C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:07:19.039Z</lastUpdated>
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  <row>
    <udiDi>08908015304781</udiDi>
    <basicUdiDi>89080153043B012MQ</basicUdiDi>
    <tradeName>TRUPCR® Influenza A/B &amp; RSV with SARS-CoV-2 RT qPCR Kit</tradeName>
    <deviceName>TRUPCR® Influenza A/B &amp; RSV with SARS-CoV-2 RT qPCR Kit</deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070304</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B012/C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:07:12.637Z</lastUpdated>
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  <row>
    <udiDi>08908015304774</udiDi>
    <basicUdiDi>89080153043B304N8</basicUdiDi>
    <tradeName>TRUPCR® SARS-CoV-2 RT qPCR Kit</tradeName>
    <deviceName>TRUPCR® SARS-CoV-2 RT qPCR Kit</deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070304</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B304</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:07:11.833Z</lastUpdated>
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  <row>
    <udiDi>08906213930030</udiDi>
    <basicUdiDi>89080153043B221N3</basicUdiDi>
    <tradeName>TRUPCRÂ® Flu Panel with RSV detection Kit</tradeName>
    <deviceName>TRUPCRÂ® Flu Panel with RSV detection Kit</deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070304</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B221/C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:02:55.431Z</lastUpdated>
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    <udiDi>06974849368680</udiDi>
    <basicUdiDi>697484936RT177AVK</basicUdiDi>
    <tradeName>Freeze-dried Six Respiratory Pathogens Nucleic Acid Detection Kit  (Fluorescence PCR)</tradeName>
    <deviceName>Freeze-dried Six Respiratory Pathogens Nucleic Acid Detection Kit  (Fluorescence PCR)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-RT177A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:36:43.313Z</lastUpdated>
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    <udiDi>03760322820072</udiDi>
    <basicUdiDi>376032282DINFSCFRRK</basicUdiDi>
    <tradeName>RespiGUARD4plex</tradeName>
    <deviceName>RespiGUARD4plex</deviceName>
    <manufacturerName>APPOLON BIOTECK</manufacturerName>
    <manufacturerSrn>FR-MF-000022234</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070304</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB0024</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T12:25:30.876Z</lastUpdated>
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    <udiDi>03532679915929</udiDi>
    <basicUdiDi>353267F00189P9B</basicUdiDi>
    <tradeName>BIOSYNEX AMPLIQUICK Fecal Virology</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000014073</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3150047_SEC01</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:27:03.517Z</lastUpdated>
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    <udiDi>08680018942961</udiDi>
    <basicUdiDi>868001894PCRABVIP3SQ</basicUdiDi>
    <tradeName>Anatolia Geneworks</tradeName>
    <deviceName>Bosphore Viral Infections in the Immunosuppressed Panel Kit</deviceName>
    <manufacturerName>Anatolia Tani ve Biyoteknoloji Urunleri Arastirma Gelistirme San. ve Tic. A.S.</manufacturerName>
    <manufacturerSrn>TR-MF-000022487</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070399</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABVIP2</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T14:06:41.621Z</lastUpdated>
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    <udiDi>08680018942954</udiDi>
    <basicUdiDi>868001894PCRABVIP3SQ</basicUdiDi>
    <tradeName>Anatolia Geneworks</tradeName>
    <deviceName>Bosphore Viral Infections in the Immunosuppressed Panel Kit</deviceName>
    <manufacturerName>Anatolia Tani ve Biyoteknoloji Urunleri Arastirma Gelistirme San. ve Tic. A.S.</manufacturerName>
    <manufacturerSrn>TR-MF-000022487</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070399</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABVIP1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T14:06:35.615Z</lastUpdated>
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    <udiDi>08680018941353</udiDi>
    <basicUdiDi>868001894PCRABVIP3SQ</basicUdiDi>
    <tradeName>Anatolia Geneworks</tradeName>
    <deviceName>Bosphore Viral Infections in the Immunosuppressed Panel Kit</deviceName>
    <manufacturerName>Anatolia Tani ve Biyoteknoloji Urunleri Arastirma Gelistirme San. ve Tic. A.S.</manufacturerName>
    <manufacturerSrn>TR-MF-000022487</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070399</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABVIP3</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T14:06:32.028Z</lastUpdated>
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