<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-LII-E201E1PZ</udiDi>
    <basicUdiDi>B-LII-E201E1PZ</basicUdiDi>
    <tradeName>One Step Estradiol (E2) Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Newlink Biotech co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045176</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LII-E201E1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:30:14.448Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C11-ALC01A1FY</udiDi>
    <basicUdiDi>B-C11-ALC01A1FY</basicUdiDi>
    <tradeName>One Step Alcohol (ALC) Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Newlink Biotech co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045176</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C11-ALC01A1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:30:14.428Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C11-ALC01A8GE</udiDi>
    <basicUdiDi>B-C11-ALC01A8GE</basicUdiDi>
    <tradeName>One Step Alcohol (ALC) Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Newlink Biotech co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045176</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C11-ALC01A8</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:30:14.405Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C11-ALC01C1G6</udiDi>
    <basicUdiDi>B-C11-ALC01C1G6</basicUdiDi>
    <tradeName>One Step Alcohol (ALC) Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Newlink Biotech co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045176</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C11-ALC01C1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:30:14.383Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C11-ALC01C8GL</udiDi>
    <basicUdiDi>B-C11-ALC01C8GL</basicUdiDi>
    <tradeName>One Step Alcohol (ALC) Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Newlink Biotech co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045176</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C11-ALC01C8</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:30:14.368Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C11-ALC01E1GC</udiDi>
    <basicUdiDi>B-C11-ALC01E1GC</basicUdiDi>
    <tradeName>One Step Alcohol (ALC) Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Newlink Biotech co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045176</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C11-ALC01E1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:30:14.351Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-F11-AFP01C3M8</udiDi>
    <basicUdiDi>B-F11-AFP01C3M8</basicUdiDi>
    <tradeName>Alpha-Fetoprotein (AFP) Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Newlink Biotech co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045176</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F11-AFP01C3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:30:14.331Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-F11-AFP01C4MA</udiDi>
    <basicUdiDi>B-F11-AFP01C4MA</basicUdiDi>
    <tradeName>Alpha-Fetoprotein (AFP) Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Newlink Biotech co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045176</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F11-AFP01C4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:30:14.310Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-F11-ASO01C3S6</udiDi>
    <basicUdiDi>B-F11-ASO01C3S6</basicUdiDi>
    <tradeName>Anti-streptolysin O (ASO) Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Newlink Biotech co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045176</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F11-ASO01C3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:30:14.289Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-F11-CA72401C4TU</udiDi>
    <basicUdiDi>B-F11-CA72401C4TU</basicUdiDi>
    <tradeName>CA72-4 Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Newlink Biotech co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045176</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F11-CA72401C4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:30:14.265Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-F11-CEA01C3GQ</udiDi>
    <basicUdiDi>B-F11-CEA01C3GQ</basicUdiDi>
    <tradeName>Carcinoembryonic Antigen (CEA) Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Newlink Biotech co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045176</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F11-CEA01C3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:30:14.249Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-F11-CEA01C4GS</udiDi>
    <basicUdiDi>B-F11-CEA01C4GS</basicUdiDi>
    <tradeName>Carcinoembryonic Antigen (CEA) Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Newlink Biotech co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045176</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F11-CEA01C4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:30:14.234Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-F11-CRP01C4T8</udiDi>
    <basicUdiDi>B-F11-CRP01C4T8</basicUdiDi>
    <tradeName>C-reactive protein (CRP) Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Newlink Biotech co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045176</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F11-CRP01C4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:30:14.219Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-F11-CSC01C4P6</udiDi>
    <basicUdiDi>B-F11-CSC01C4P6</basicUdiDi>
    <tradeName>CRP/SAA Combo Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Newlink Biotech co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045176</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F11-CSC01C4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:30:14.197Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-F11-FOB01C6NW</udiDi>
    <basicUdiDi>B-F11-FOB01C6NW</basicUdiDi>
    <tradeName>Fecal Occult Blood (FOB) Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Newlink Biotech co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045176</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F11-FOB01C6</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:30:14.175Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-F11-HBP01C4PD</udiDi>
    <basicUdiDi>B-F11-HBP01C4PD</basicUdiDi>
    <tradeName>Heparin-Binding Protein(HBP) Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Newlink Biotech co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045176</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F11-HBP01C4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:30:14.155Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-F11-HBPC01C4MZ</udiDi>
    <basicUdiDi>B-F11-HBPC01C4MZ</basicUdiDi>
    <tradeName>HBP/PCT Combo Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Newlink Biotech co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045176</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F11-HBPC01C4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:30:14.143Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-F11-IL601C4KD</udiDi>
    <basicUdiDi>B-F11-IL601C4KD</basicUdiDi>
    <tradeName>Interleukin-6 (IL-6) Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Newlink Biotech co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045176</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F11-IL601C4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:30:14.127Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-F11-ILPC01C4TW</udiDi>
    <basicUdiDi>B-F11-ILPC01C4TW</basicUdiDi>
    <tradeName>IL6/PCT Combo Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Newlink Biotech co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045176</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F11-ILPC01C4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:30:14.097Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-F11-PCT01C4VE</udiDi>
    <basicUdiDi>B-F11-PCT01C4VE</basicUdiDi>
    <tradeName>Procalcitonin (PCT) Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Newlink Biotech co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045176</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F11-PCT01C4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:30:14.071Z</lastUpdated>
  </row>
</eudamedExport>