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<eudamedExport entity="devices">
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    <udiDi>06973642382527</udiDi>
    <basicUdiDi>B-06973642382527</basicUdiDi>
    <tradeName>06973642382527</tradeName>
    <deviceName>Tigsun Flu A/B, RSV, COVID-19 Ag Combo Test</deviceName>
    <manufacturerName>Beijing Tigsun Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034480</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>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:28:53.789Z</lastUpdated>
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  <row>
    <udiDi>06973642382510</udiDi>
    <basicUdiDi>B-06973642382510</basicUdiDi>
    <tradeName>06973642382510</tradeName>
    <deviceName>Tigsun Flu A/B, RSV, COVID-19 Ag Combo Test</deviceName>
    <manufacturerName>Beijing Tigsun Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034480</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>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:28:53.277Z</lastUpdated>
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  <row>
    <udiDi>06973642382534</udiDi>
    <basicUdiDi>B-06973642382534</basicUdiDi>
    <tradeName>06973642382534</tradeName>
    <deviceName>Tigsun Flu A/B, RSV, COVID-19 Ag Combo Test</deviceName>
    <manufacturerName>Beijing Tigsun Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034480</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>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:28:50.303Z</lastUpdated>
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  <row>
    <udiDi>06973642382503</udiDi>
    <basicUdiDi>B-06973642382503</basicUdiDi>
    <tradeName>06973642382503</tradeName>
    <deviceName>Tigsun Flu A/B, RSV, COVID-19 Ag Combo Test</deviceName>
    <manufacturerName>Beijing Tigsun Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034480</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>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:28:48.067Z</lastUpdated>
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  <row>
    <udiDi>06973642382497</udiDi>
    <basicUdiDi>B-06973642382497</basicUdiDi>
    <tradeName>06973642382497</tradeName>
    <deviceName>Tigsun Flu A/B, RSV, COVID-19 Ag Combo Test</deviceName>
    <manufacturerName>Beijing Tigsun Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034480</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>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:28:32.194Z</lastUpdated>
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  <row>
    <udiDi>06973642382480</udiDi>
    <basicUdiDi>B-06973642382480</basicUdiDi>
    <tradeName>06973642382480</tradeName>
    <deviceName>Tigsun Flu A/B, RSV, COVID-19 Ag Combo Test</deviceName>
    <manufacturerName>Beijing Tigsun Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034480</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>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:28:31.395Z</lastUpdated>
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    <udiDi>06973642382473</udiDi>
    <basicUdiDi>B-06973642382473</basicUdiDi>
    <tradeName>06973642382473</tradeName>
    <deviceName>Tigsun Flu A/B, RSV, COVID-19 Ag Combo Test</deviceName>
    <manufacturerName>Beijing Tigsun Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034480</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>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:28:30.596Z</lastUpdated>
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  <row>
    <udiDi>06973642382466</udiDi>
    <basicUdiDi>B-06973642382466</basicUdiDi>
    <tradeName>06973642382466</tradeName>
    <deviceName>Tigsun Flu A/B, COVID-19 Ag Combo Test</deviceName>
    <manufacturerName>Beijing Tigsun Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034480</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>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:28:29.791Z</lastUpdated>
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  <row>
    <udiDi>06973642382459</udiDi>
    <basicUdiDi>B-06973642382459</basicUdiDi>
    <tradeName>06973642382459</tradeName>
    <deviceName>Tigsun Flu A/B, COVID-19 Ag Combo Test</deviceName>
    <manufacturerName>Beijing Tigsun Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034480</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>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:28:25.798Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973642382442</udiDi>
    <basicUdiDi>B-06973642382442</basicUdiDi>
    <tradeName>06973642382442</tradeName>
    <deviceName>Tigsun Flu A/B, COVID-19 Ag Combo Test</deviceName>
    <manufacturerName>Beijing Tigsun Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034480</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>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:28:24.993Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973642382435</udiDi>
    <basicUdiDi>B-06973642382435</basicUdiDi>
    <tradeName>06973642382435</tradeName>
    <deviceName>Tigsun Flu A/B, COVID-19 Ag Combo Test</deviceName>
    <manufacturerName>Beijing Tigsun Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034480</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>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:28:24.193Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973642382428</udiDi>
    <basicUdiDi>B-06973642382428</basicUdiDi>
    <tradeName>06973642382428</tradeName>
    <deviceName>Tigsun Flu A/B, COVID-19 Ag Combo Test</deviceName>
    <manufacturerName>Beijing Tigsun Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034480</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>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:28:23.395Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973642382411</udiDi>
    <basicUdiDi>B-06973642382411</basicUdiDi>
    <tradeName>06973642382411</tradeName>
    <deviceName>Tigsun Flu A/B, COVID-19 Ag Combo Test</deviceName>
    <manufacturerName>Beijing Tigsun Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034480</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>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:28:19.400Z</lastUpdated>
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  <row>
    <udiDi>06973642382404</udiDi>
    <basicUdiDi>B-06973642382404</basicUdiDi>
    <tradeName>06973642382404</tradeName>
    <deviceName>Tigsun Flu A/B, COVID-19 Ag Combo Test</deviceName>
    <manufacturerName>Beijing Tigsun Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034480</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>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:28:18.594Z</lastUpdated>
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    <udiDi>06973642382398</udiDi>
    <basicUdiDi>B-06973642382398</basicUdiDi>
    <tradeName>06973642382398</tradeName>
    <deviceName>Tigsun Flu A/B, COVID-19 Ag Combo Test</deviceName>
    <manufacturerName>Beijing Tigsun Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034480</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>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:28:17.790Z</lastUpdated>
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    <udiDi>06973642382381</udiDi>
    <basicUdiDi>B-06973642382381</basicUdiDi>
    <tradeName>06973642382381</tradeName>
    <deviceName>Tigsun Flu A/B, COVID-19 Ag Combo Test</deviceName>
    <manufacturerName>Beijing Tigsun Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034480</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>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:28:16.995Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973181850501</udiDi>
    <basicUdiDi>B-06973181850501</basicUdiDi>
    <tradeName>StrongStep® Influenza A/B &amp; RSV Multiplex Real-Time PCR Kit</tradeName>
    <deviceName>Influenza A/B &amp; RSV Multiplex Real-Time PCR Kit</deviceName>
    <manufacturerName>Nanjing Liming Bio-products Co. Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041298</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070304</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>510030</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:52:54.992Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973181850495</udiDi>
    <basicUdiDi>B-06973181850495</basicUdiDi>
    <tradeName>StrongStep® Influenza A/B Multiplex RT-qPCR Kit</tradeName>
    <deviceName>Influenza A/B Multiplex RT-qPCR Kit</deviceName>
    <manufacturerName>Nanjing Liming Bio-products Co. Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041298</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070304</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>510020</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:52:50.985Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973181850143</udiDi>
    <basicUdiDi>B-06973181850143</basicUdiDi>
    <tradeName>StrongStep® Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit (detection for three genes)</tradeName>
    <deviceName>Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit (detection for three genes)</deviceName>
    <manufacturerName>Nanjing Liming Bio-products Co. Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041298</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070304</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>500190</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:52:15.719Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973181850068</udiDi>
    <basicUdiDi>B-06973181850068</basicUdiDi>
    <tradeName>StrongStep® SARS-CoV-2 &amp; Influenza A/B Multiplex Real-Time PCR Kit</tradeName>
    <deviceName>SARS-CoV-2 &amp; Influenza A/B Multiplex Real-Time PCR Kit</deviceName>
    <manufacturerName>Nanjing Liming Bio-products Co. Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041298</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070304</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>510010</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:52:09.320Z</lastUpdated>
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</eudamedExport>