<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>86060147127596</udiDi>
    <basicUdiDi>86060147183932V</basicUdiDi>
    <tradeName>COPROSS System liquid</tradeName>
    <deviceName>COPROSS System liquid</deviceName>
    <manufacturerName>NEOMEDICA DOO NIŠ</manufacturerName>
    <manufacturerSrn>RS-MF-000021305</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020185</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C1905CL</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:09:07.214Z</lastUpdated>
  </row>
  <row>
    <udiDi>86060147122928</udiDi>
    <basicUdiDi>86060147183862Y</basicUdiDi>
    <tradeName>COPROSS SANITIZING SOLUTION</tradeName>
    <deviceName>COPROSS SANITIZING SOLUTION</deviceName>
    <manufacturerName>NEOMEDICA DOO NIŠ</manufacturerName>
    <manufacturerSrn>RS-MF-000021305</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020185</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C1904CS</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:09:06.424Z</lastUpdated>
  </row>
  <row>
    <udiDi>86060147122850</udiDi>
    <basicUdiDi>86060147184922Y</basicUdiDi>
    <tradeName>COPROSS WASH B</tradeName>
    <deviceName>COPROSS WASH B</deviceName>
    <manufacturerName>NEOMEDICA DOO NIŠ</manufacturerName>
    <manufacturerSrn>RS-MF-000021305</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020185</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C1902CB</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:09:03.215Z</lastUpdated>
  </row>
  <row>
    <udiDi>86060147122782</udiDi>
    <basicUdiDi>860601471837933</basicUdiDi>
    <tradeName>COPROSS WASH A</tradeName>
    <deviceName>COPROSS WASH A</deviceName>
    <manufacturerName>NEOMEDICA DOO NIŠ</manufacturerName>
    <manufacturerSrn>RS-MF-000021305</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020185</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C1901CA</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:09:02.420Z</lastUpdated>
  </row>
  <row>
    <udiDi>86060147122614</udiDi>
    <basicUdiDi>8606014712261YW</basicUdiDi>
    <tradeName>COPROSS</tradeName>
    <deviceName>COPROSS</deviceName>
    <manufacturerName>NEOMEDICA DOO NIŠ</manufacturerName>
    <manufacturerSrn>RS-MF-000021305</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C100Y</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:09:01.616Z</lastUpdated>
  </row>
  <row>
    <udiDi>8435287397055</udiDi>
    <basicUdiDi>843528739705JG</basicUdiDi>
    <tradeName>JUNO Automatic eCLIA Analyzer</tradeName>
    <deviceName>JUNO Automatic eCLIA Analyzer</deviceName>
    <manufacturerName>Linear Chemicals S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000003284</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7700010</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:59:02.726Z</lastUpdated>
  </row>
  <row>
    <udiDi>8435287397000</udiDi>
    <basicUdiDi>843528739700J6</basicUdiDi>
    <tradeName>Aura POCT CLIA Analyzer</tradeName>
    <deviceName>Aura POCT CLIA Analyzer</deviceName>
    <manufacturerName>Linear Chemicals S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000003284</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7700000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:59:00.619Z</lastUpdated>
  </row>
  <row>
    <udiDi>8435287393309</udiDi>
    <basicUdiDi>843528739330HT</basicUdiDi>
    <tradeName>KROMA Plus iT Automatic Immunological Analyzer</tradeName>
    <deviceName>KROMA Plus iT Automatic Immunological Analyzer</deviceName>
    <manufacturerName>Linear Chemicals S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000003284</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3800070</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:58:22.637Z</lastUpdated>
  </row>
  <row>
    <udiDi>8435287393101</udiDi>
    <basicUdiDi>843528739310HM</basicUdiDi>
    <tradeName>KROMA iT Automatic Immunological Analyzer</tradeName>
    <deviceName>KROMA iT Automatic Immunological Analyzer</deviceName>
    <manufacturerName>Linear Chemicals S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000003284</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3800050</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:58:18.630Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195126000741</udiDi>
    <basicUdiDi>84307930458034R</basicUdiDi>
    <tradeName>Aptiva Instrument System Cuvettes</tradeName>
    <deviceName>Instrument System Cuvettes</deviceName>
    <manufacturerName>Inova Diagnostics. Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017851</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020185</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC1005</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:20:36.901Z</lastUpdated>
  </row>
  <row>
    <udiDi>08426951307227</udiDi>
    <basicUdiDi>84269513072276Z</basicUdiDi>
    <tradeName>Aptiva® Multi-Analyte Instrument</tradeName>
    <deviceName>Aptiva® Multi-Analyte Instrument</deviceName>
    <manufacturerName>Inova Diagnostics. Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017851</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AP5000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:14:14.884Z</lastUpdated>
  </row>
  <row>
    <udiDi>08426950865131</udiDi>
    <basicUdiDi>84269508651319P</basicUdiDi>
    <tradeName>QUANTA-Lyser® 3000 IFA</tradeName>
    <deviceName>QUANTA-Lyser® 3000 IFA</deviceName>
    <manufacturerName>Inova Diagnostics. Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017851</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020102</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 250 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS3002</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:12:57.163Z</lastUpdated>
  </row>
  <row>
    <udiDi>08426950865100</udiDi>
    <basicUdiDi>84269508651009C</basicUdiDi>
    <tradeName>QUANTA-Lyser® 3000 ELISA/IFA + Incubator</tradeName>
    <deviceName>QUANTA-Lyser® 3000 ELISA/IFA + Incubator</deviceName>
    <manufacturerName>Inova Diagnostics. Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017851</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020102</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 250 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS3000i</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:12:55.571Z</lastUpdated>
  </row>
  <row>
    <udiDi>08426950865094</udiDi>
    <basicUdiDi>8426950865094AA</basicUdiDi>
    <tradeName>QUANTA-Lyser® 3000 ELISA/IFA</tradeName>
    <deviceName>QUANTA-Lyser® 3000  ELISA/IFA</deviceName>
    <manufacturerName>Inova Diagnostics. Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017851</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020102</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 250 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS3000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:12:52.380Z</lastUpdated>
  </row>
  <row>
    <udiDi>08426950621614</udiDi>
    <basicUdiDi>84269506216147E</basicUdiDi>
    <tradeName>NOVA View® Automated Fluorescence Microscope</tradeName>
    <deviceName>NOVA View® Automated Fluorescence Microscope</deviceName>
    <manufacturerName>Inova Diagnostics. Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017851</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020104</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput &gt; 700 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NV2000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:11:34.742Z</lastUpdated>
  </row>
  <row>
    <udiDi>08426950554448</udiDi>
    <basicUdiDi>84269506397259T</basicUdiDi>
    <tradeName>BIO-FLASH Cuvettes</tradeName>
    <deviceName>BIO-FLASH</deviceName>
    <manufacturerName>Biokit S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000002406</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020185</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3000-8206</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:10:44.165Z</lastUpdated>
  </row>
  <row>
    <udiDi>08059616660513</udiDi>
    <basicUdiDi>805961666BLOTMODULETU</basicUdiDi>
    <tradeName>BLOT MODULE</tradeName>
    <deviceName>BLOT MODULE</deviceName>
    <manufacturerName>DAS Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000035583</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020180</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OR-0600</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:36:26.980Z</lastUpdated>
  </row>
  <row>
    <udiDi>08059616660179</udiDi>
    <basicUdiDi>805961666APELISAIFABLOTMA</basicUdiDi>
    <tradeName>AP22 IF BLOT ELITE</tradeName>
    <deviceName>AP ELISA-IFA-BLOT</deviceName>
    <manufacturerName>DAS Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000035583</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020102</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 250 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OR-102403</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:36:20.555Z</lastUpdated>
  </row>
  <row>
    <udiDi>08059616660148</udiDi>
    <basicUdiDi>805961666APELISAIFAG2</basicUdiDi>
    <tradeName>AP22 IF ELITE</tradeName>
    <deviceName>AP ELISA-IFA</deviceName>
    <manufacturerName>DAS Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000035583</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020102</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 250 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OR-102402</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:36:18.168Z</lastUpdated>
  </row>
  <row>
    <udiDi>08059616660131</udiDi>
    <basicUdiDi>805961666APELISATZ</basicUdiDi>
    <tradeName>AP22 ELITE</tradeName>
    <deviceName>AP ELISA</deviceName>
    <manufacturerName>DAS Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000035583</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020102</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 250 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OR-102401</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:36:16.559Z</lastUpdated>
  </row>
</eudamedExport>