<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-F51-LEGE2</udiDi>
    <basicUdiDi>B-F51-LEGE2</basicUdiDi>
    <tradeName>Fluorescence lmmunoassay Control (Legionella pneumophila)</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>F51-LEG</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:29:54.539Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-F51-VB12SV</udiDi>
    <basicUdiDi>B-F51-VB12SV</basicUdiDi>
    <tradeName>Fluorescence lmmunoassay Control (Vitamin B12)</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>F51-VB12</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:29:54.521Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-F51-NCGE6</udiDi>
    <basicUdiDi>B-F51-NCGE6</basicUdiDi>
    <tradeName>Fluorescence lmmunoassay Control (SARS-CoV-2 Antigen)</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>F51-NCG</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:29:54.499Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-F51-VDZC</udiDi>
    <basicUdiDi>B-F51-VDZC</basicUdiDi>
    <tradeName>FIA Control-Vitamin D</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>F51-VD</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:29:54.475Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-F51-P4XU</udiDi>
    <basicUdiDi>B-F51-P4XU</basicUdiDi>
    <tradeName>Fluorescence lmmunoassay Control-Progesterone (P4)</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>F51-P4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:29:54.452Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-F51-PRLG7</udiDi>
    <basicUdiDi>B-F51-PRLG7</basicUdiDi>
    <tradeName>Fluorescence lmmunoassay Control (PRL)</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>F51-PRL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:29:54.434Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-L51-AD01PR3X</udiDi>
    <basicUdiDi>B-L51-AD01PR3X</basicUdiDi>
    <tradeName>Adenovirus Control</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>L51-AD01PR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:29:54.414Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-L51-AMH01P8Y</udiDi>
    <basicUdiDi>B-L51-AMH01P8Y</basicUdiDi>
    <tradeName>AMH Antigen Control</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>L51-AMH01P</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:29:54.394Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-F51-RACEC</udiDi>
    <basicUdiDi>B-F51-RACEC</basicUdiDi>
    <tradeName>Fluorescence lmmunoassay Control (Rotavirus and Adenovirus Combo)</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>F51-RAC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:29:54.374Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-L51-CD03PR53</udiDi>
    <basicUdiDi>B-L51-CD03PR53</basicUdiDi>
    <tradeName>Clostridium difficile GDH+Toxin A+Toxin B Control</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>L51-CD03PR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:29:54.355Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-F51-RSVH8</udiDi>
    <basicUdiDi>B-F51-RSVH8</basicUdiDi>
    <tradeName>Fluorescence lmmunoassay Control (RSV)</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>F51-RSV</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:29:54.338Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-L51-CDG01PRWW</udiDi>
    <basicUdiDi>B-L51-CDG01PRWW</basicUdiDi>
    <tradeName>Clostridium difficile GDH Control</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>L51-CDG01PR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:29:54.316Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-F51-SPZT</udiDi>
    <basicUdiDi>B-F51-SPZT</basicUdiDi>
    <tradeName>Fluorescence lmmunoassay Control (Streptococcus pneumoniae)</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>F51-SP</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:29:54.295Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-L51-CDT02PR3M</udiDi>
    <basicUdiDi>B-L51-CDT02PR3M</basicUdiDi>
    <tradeName>Clostridium difficile Toxin A + Toxin B Control</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>L51-CDT02PR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:29:54.273Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-F51-STAG6</udiDi>
    <basicUdiDi>B-F51-STAG6</basicUdiDi>
    <tradeName>Fluorescence lmmunoassay Control (Strep A)</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>F51-STA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:29:54.253Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-F51-SYPHK</udiDi>
    <basicUdiDi>B-F51-SYPHK</basicUdiDi>
    <tradeName>Fluorescence lmmunoassay Control (Syphilis)</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>F51-SYP</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:29:54.231Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-L51-DEN01R8V</udiDi>
    <basicUdiDi>B-L51-DEN01R8V</basicUdiDi>
    <tradeName>Dengue IgG/IgM Control</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>L51-DEN01R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:29:54.210Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-L51-DES01P9U</udiDi>
    <basicUdiDi>B-L51-DES01P9U</basicUdiDi>
    <tradeName>Dengue NS1 Control</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>L51-DES01P</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:29:54.194Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-F51-T3Y6</udiDi>
    <basicUdiDi>B-F51-T3Y6</basicUdiDi>
    <tradeName>Fluorescence lmmunoassay Control (T3)</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>F51-T3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:29:54.176Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-F51-T4Y8</udiDi>
    <basicUdiDi>B-F51-T4Y8</basicUdiDi>
    <tradeName>Fluorescence lmmunoassay Control (T4)</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>F51-T4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:29:54.154Z</lastUpdated>
  </row>
</eudamedExport>