<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-L11-MOP01C75E</udiDi>
    <basicUdiDi>B-L11-MOP01C75E</basicUdiDi>
    <tradeName>One Step Single Drug Test (Hair)</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>L11-MOP01C7</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:30:28.723Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-L11-MXB01C443</udiDi>
    <basicUdiDi>B-L11-MXB01C443</basicUdiDi>
    <tradeName>One Step Monkeypox Virus Antibody 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>L11-MXB01C4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:30:28.705Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-L11-MXG01C45S</udiDi>
    <basicUdiDi>B-L11-MXG01C45S</basicUdiDi>
    <tradeName>One Step Monkeypox Virus Antigen 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>L11-MXG01C4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:30:28.683Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-L11-OXY01C7D8</udiDi>
    <basicUdiDi>B-L11-OXY01C7D8</basicUdiDi>
    <tradeName>One Step Single Drug Test (Hair)</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>L11-OXY01C7</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:30:28.667Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-L11-PCP01C725</udiDi>
    <basicUdiDi>B-L11-PCP01C725</basicUdiDi>
    <tradeName>One Step Single Drug Test (Hair)</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>L11-PCP01C7</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:30:28.654Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-L11-RTB05C55S</udiDi>
    <basicUdiDi>B-L11-RTB05C55S</basicUdiDi>
    <tradeName>One Step Adenovirus/RSV/HMPV/HPIV/Influenza A+B Combo 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>L11-RTB05C5</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:30:28.642Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-L11-SH02C66Z</udiDi>
    <basicUdiDi>B-L11-SH02C66Z</basicUdiDi>
    <tradeName>One Step Shigella 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>L11-SH02C6</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:30:28.622Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-L11-SHF01C629</udiDi>
    <basicUdiDi>B-L11-SHF01C629</basicUdiDi>
    <tradeName>One Step Shigella Flexneri Antigen 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>L11-SHF01C6</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:30:28.595Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-L11-SHS01C66Q</udiDi>
    <basicUdiDi>B-L11-SHS01C66Q</basicUdiDi>
    <tradeName>One Step Shigella Sonnei Antigen 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>L11-SHS01C6</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:30:28.576Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-L11-SM01C78M</udiDi>
    <basicUdiDi>B-L11-SM01C78M</basicUdiDi>
    <tradeName>One Step Single Drug Test (Hair)</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>L11-SM01C7</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:30:28.554Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-L11-STPB02C6D3</udiDi>
    <basicUdiDi>B-L11-STPB02C6D3</basicUdiDi>
    <tradeName>One Step Salmonella typhi and paratyphi B Antigen Combo 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>L11-STPB02C6</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:30:28.536Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-L11-BT01C13R</udiDi>
    <basicUdiDi>B-L11-BT01C13R</basicUdiDi>
    <tradeName>One Step Bladder Tumor Antigen 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>L11-BT01C1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:30:28.505Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-L11-CEL01C4SD</udiDi>
    <basicUdiDi>B-L11-CEL01C4SD</basicUdiDi>
    <tradeName>One Step Celiac 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>L11-CEL01C4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:30:28.488Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-L11-CHIG01C4TP</udiDi>
    <basicUdiDi>B-L11-CHIG01C4TP</basicUdiDi>
    <tradeName>One Step Chikungunya Antigen 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>L11-CHIG01C4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:30:28.462Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-L11-CT02C54K</udiDi>
    <basicUdiDi>B-L11-CT02C54K</basicUdiDi>
    <tradeName>One Step Candida albicans and Trichomonas Vaginalis Combo 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>L11-CT02C5</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:30:28.437Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-L11-CTBP04F63A</udiDi>
    <basicUdiDi>B-L11-CTBP04F63A</basicUdiDi>
    <tradeName>One Step Calprotectin/Transferrin/FOB/Hb-Hp Combo 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>L11-CTBP04F6</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:30:28.415Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-L11-DME01C4TR</udiDi>
    <basicUdiDi>B-L11-DME01C4TR</basicUdiDi>
    <tradeName>One Step Dust Mite IgE 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>L11-DME01C4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:30:28.394Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-L11-EV01C65Y</udiDi>
    <basicUdiDi>B-L11-EV01C65Y</basicUdiDi>
    <tradeName>One Step Enterovirus Antigen 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>L11-EV01C6</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:30:28.376Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-L11-FH02C5ZK</udiDi>
    <basicUdiDi>B-L11-FH02C5ZK</basicUdiDi>
    <tradeName>One Step Influenza A/B + H5N1 Antigen Combo 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>L11-FH02C5</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:30:28.361Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-L11-FILG01C4X8</udiDi>
    <basicUdiDi>B-L11-FILG01C4X8</basicUdiDi>
    <tradeName>One Step Filariasis Antigen 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>L11-FILG01C4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:30:28.342Z</lastUpdated>
  </row>
</eudamedExport>