<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04719892999014</udiDi>
    <basicUdiDi>471989299Analyzer8A</basicUdiDi>
    <tradeName>Agnitio BioIC Analyzer</tradeName>
    <deviceName>Agnitio BioIC Analyzer</deviceName>
    <manufacturerName>AGNITIO SCIENCE &amp;TECHNOLOGY,INC.</manufacturerName>
    <manufacturerSrn>TW-MF-000040942</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BA-G2000 series</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:32:58.981Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719892991155</udiDi>
    <basicUdiDi>471989299Allergy8G</basicUdiDi>
    <tradeName>BioIC Allergen Specific-IgE Detection Kit</tradeName>
    <deviceName>BioIC Allergen Specific-IgE Detection Kit</deviceName>
    <manufacturerName>AGNITIO SCIENCE &amp;TECHNOLOGY,INC.</manufacturerName>
    <manufacturerSrn>TW-MF-000040942</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AP40</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:32:58.265Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719892999021</udiDi>
    <basicUdiDi>471989299Analyzer8A</basicUdiDi>
    <tradeName>Agnitio BioIC Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AGNITIO SCIENCE &amp;TECHNOLOGY,INC.</manufacturerName>
    <manufacturerSrn>TW-MF-000040942</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BA-G2012 series</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:07:26.123Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719892999052</udiDi>
    <basicUdiDi>471989299Analyzer8A</basicUdiDi>
    <tradeName>Agnitio BioIC Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AGNITIO SCIENCE &amp;TECHNOLOGY,INC.</manufacturerName>
    <manufacturerSrn>TW-MF-000040942</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>BA400 series</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:07:26.113Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719892999069</udiDi>
    <basicUdiDi>471989299Analyzer8A</basicUdiDi>
    <tradeName>Agnitio BioIC Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AGNITIO SCIENCE &amp;TECHNOLOGY,INC.</manufacturerName>
    <manufacturerSrn>TW-MF-000040942</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>BA2400 series</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:07:26.097Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719892999076</udiDi>
    <basicUdiDi>471989299Analyzer8A</basicUdiDi>
    <tradeName>Agnitio BioIC Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AGNITIO SCIENCE &amp;TECHNOLOGY,INC.</manufacturerName>
    <manufacturerSrn>TW-MF-000040942</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>BA1200 series</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:07:26.084Z</lastUpdated>
  </row>
</eudamedExport>