<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06954414795578</udiDi>
    <basicUdiDi>695441479557KZ</basicUdiDi>
    <tradeName>Metis 6000 Modular System (Integrated Clinical Chemistry and Immunochemistry)</tradeName>
    <deviceName>Metis 6000 Modular System (Integrated Clinical Chemistry and Immunochemistry)</deviceName>
    <manufacturerName>Getein Biotech, Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017986</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>W0201030102</emdnCode>
    <emdnDescription>MIXED PANEL MULTIPARAMETER ANALYSERS - MODERATE ROUTINE (Throughput &gt; 800 and &lt;= 2000 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:50:31.480Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414229553</udiDi>
    <basicUdiDi>0405686902224V9</basicUdiDi>
    <tradeName>Atellica CI Analyzer</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_A_INST_Atellica CI 1900 Analyzer</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201030102</emdnCode>
    <emdnDescription>MIXED PANEL MULTIPARAMETER ANALYSERS - MODERATE ROUTINE (Throughput &gt; 800 and &lt;= 2000 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10947347</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:33:23.642Z</lastUpdated>
  </row>
</eudamedExport>