<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>07350144650030</udiDi>
    <basicUdiDi>735014465GT048A</basicUdiDi>
    <tradeName>QuickMIC GN</tradeName>
    <deviceName>QuickMIC GN</deviceName>
    <manufacturerName>Gradientech AB</manufacturerName>
    <manufacturerSrn>SE-MF-000017760</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080107</emdnCode>
    <emdnDescription>GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>43-001-10</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:06:49.049Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941967237839</udiDi>
    <basicUdiDi>6973262860011923</basicUdiDi>
    <tradeName>06941967237839</tradeName>
    <deviceName>Ab Matrix Solution</deviceName>
    <manufacturerName>Zybio Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000003349</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080113</emdnCode>
    <emdnDescription>OTHER AUTOMATED SUSCEPTIBILITY TESTING (INCL CONSUMABLES...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>052304001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:24:50.611Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973049096119</udiDi>
    <basicUdiDi>697304909Model61UJ</basicUdiDi>
    <tradeName>AutoMic-i600</tradeName>
    <deviceName>Automated Microorganism Identification and Antimicrobial Susceptibility Testing Analyzer</deviceName>
    <manufacturerName>Autobio Labtec Instruments Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012110</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080101</emdnCode>
    <emdnDescription>GRAM NEGATIVE IDENTIFICATION - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05021</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T10:30:48.703Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904726849484</udiDi>
    <basicUdiDi>59047268494PanelUNI-2.0VQ</basicUdiDi>
    <tradeName>BACTEROMIC Panel UNI 2.0</tradeName>
    <deviceName>BACTEROMIC Panel UNI 2.0</deviceName>
    <manufacturerName>BACTEROMIC SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ</manufacturerName>
    <manufacturerSrn>PL-MF-000040114</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080113</emdnCode>
    <emdnDescription>OTHER AUTOMATED SUSCEPTIBILITY TESTING (INCL CONSUMABLES...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BQS-520011</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:59:40.495Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904726849415</udiDi>
    <basicUdiDi>59047268494PanelFASTI32</basicUdiDi>
    <tradeName>BACTEROMIC Panel UNI FAST</tradeName>
    <deviceName>BACTEROMIC Panel UNI FAST (FAS01-I)</deviceName>
    <manufacturerName>BACTEROMIC SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ</manufacturerName>
    <manufacturerSrn>PL-MF-000040114</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080113</emdnCode>
    <emdnDescription>OTHER AUTOMATED SUSCEPTIBILITY TESTING (INCL CONSUMABLES...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BQS-520014</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:59:37.262Z</lastUpdated>
  </row>
  <row>
    <udiDi>15056152713345</udiDi>
    <basicUdiDi>50561527FOS8LE</basicUdiDi>
    <tradeName>15056152713345</tradeName>
    <deviceName>Mast Uri® Plates Fosfomycin 8mg/L</deviceName>
    <manufacturerName>Mast Group Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000025209</manufacturerSrn>
    <authorisedRepresentativeName>Mast Diagnostica GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005299</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080113</emdnCode>
    <emdnDescription>OTHER AUTOMATED SUSCEPTIBILITY TESTING (INCL CONSUMABLES...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPM-FOS8</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:54:33.216Z</lastUpdated>
  </row>
  <row>
    <udiDi>15056152710917</udiDi>
    <basicUdiDi>50561527TEM16GM</basicUdiDi>
    <tradeName>15056152710917</tradeName>
    <deviceName>Mast Uri® Plates Temocillin 16mg/L</deviceName>
    <manufacturerName>Mast Group Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000025209</manufacturerSrn>
    <authorisedRepresentativeName>Mast Diagnostica GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005299</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080113</emdnCode>
    <emdnDescription>OTHER AUTOMATED SUSCEPTIBILITY TESTING (INCL CONSUMABLES...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPM-TEM16</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:54:31.610Z</lastUpdated>
  </row>
  <row>
    <udiDi>15056152710894</udiDi>
    <basicUdiDi>50561527AK8RF</basicUdiDi>
    <tradeName>15056152710894</tradeName>
    <deviceName>Mast Uri® Plates Amikacin 8mg/L</deviceName>
    <manufacturerName>Mast Group Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000025209</manufacturerSrn>
    <authorisedRepresentativeName>Mast Diagnostica GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005299</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080113</emdnCode>
    <emdnDescription>OTHER AUTOMATED SUSCEPTIBILITY TESTING (INCL CONSUMABLES...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPM-AK8</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:54:30.812Z</lastUpdated>
  </row>
  <row>
    <udiDi>15056152709515</udiDi>
    <basicUdiDi>50561527CIP25C6</basicUdiDi>
    <tradeName>15056152709515</tradeName>
    <deviceName>Mast Uri® Plates Ciprofloxacin 0.25mg/L</deviceName>
    <manufacturerName>Mast Group Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000025209</manufacturerSrn>
    <authorisedRepresentativeName>Mast Diagnostica GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005299</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080113</emdnCode>
    <emdnDescription>OTHER AUTOMATED SUSCEPTIBILITY TESTING (INCL CONSUMABLES...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPM-CIP0.25</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:54:14.893Z</lastUpdated>
  </row>
  <row>
    <udiDi>15056152706064</udiDi>
    <basicUdiDi>50561527CXM8LL</basicUdiDi>
    <tradeName>15056152706064</tradeName>
    <deviceName>Mast Uri® Plates Cefuroxime 8mg/L</deviceName>
    <manufacturerName>Mast Group Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000025209</manufacturerSrn>
    <authorisedRepresentativeName>Mast Diagnostica GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005299</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080113</emdnCode>
    <emdnDescription>OTHER AUTOMATED SUSCEPTIBILITY TESTING (INCL CONSUMABLES...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPM-CXM8</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:54:09.143Z</lastUpdated>
  </row>
  <row>
    <udiDi>15056152705999</udiDi>
    <basicUdiDi>50561527VA4TJ</basicUdiDi>
    <tradeName>15056152705999</tradeName>
    <deviceName>Mast Uri® Plates Vancomycin 4mg/L</deviceName>
    <manufacturerName>Mast Group Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000025209</manufacturerSrn>
    <authorisedRepresentativeName>Mast Diagnostica GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005299</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080113</emdnCode>
    <emdnDescription>OTHER AUTOMATED SUSCEPTIBILITY TESTING (INCL CONSUMABLES...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPM-VA4</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:54:08.337Z</lastUpdated>
  </row>
  <row>
    <udiDi>15056152702134</udiDi>
    <basicUdiDi>50561527TS238FX</basicUdiDi>
    <tradeName>15056152702134</tradeName>
    <deviceName>Mast Uri® Plates Trimethoprim 2/Sulphamethoxazole 38mg/L</deviceName>
    <manufacturerName>Mast Group Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000025209</manufacturerSrn>
    <authorisedRepresentativeName>Mast Diagnostica GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005299</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080113</emdnCode>
    <emdnDescription>OTHER AUTOMATED SUSCEPTIBILITY TESTING (INCL CONSUMABLES...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPM-TS2/38</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:54:01.951Z</lastUpdated>
  </row>
  <row>
    <udiDi>15056152702110</udiDi>
    <basicUdiDi>50561527TM4UC</basicUdiDi>
    <tradeName>15056152702110</tradeName>
    <deviceName>Mast Uri® Plates Trimethoprim 4mg/L</deviceName>
    <manufacturerName>Mast Group Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000025209</manufacturerSrn>
    <authorisedRepresentativeName>Mast Diagnostica GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005299</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080113</emdnCode>
    <emdnDescription>OTHER AUTOMATED SUSCEPTIBILITY TESTING (INCL CONSUMABLES...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPM-TM4</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:54:01.138Z</lastUpdated>
  </row>
  <row>
    <udiDi>15056152702097</udiDi>
    <basicUdiDi>50561527PTZ8Q2</basicUdiDi>
    <tradeName>15056152702097</tradeName>
    <deviceName>Mast Uri® Plates Piperacillin 8/Tazobactam 4mg/L</deviceName>
    <manufacturerName>Mast Group Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000025209</manufacturerSrn>
    <authorisedRepresentativeName>Mast Diagnostica GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005299</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080113</emdnCode>
    <emdnDescription>OTHER AUTOMATED SUSCEPTIBILITY TESTING (INCL CONSUMABLES...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPM-PTZ8</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:53:56.335Z</lastUpdated>
  </row>
  <row>
    <udiDi>15056152702073</udiDi>
    <basicUdiDi>50561527NI64JC</basicUdiDi>
    <tradeName>15056152702073</tradeName>
    <deviceName>Mast Uri® Plates Nitrofurantoin 64mg/L</deviceName>
    <manufacturerName>Mast Group Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000025209</manufacturerSrn>
    <authorisedRepresentativeName>Mast Diagnostica GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005299</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080113</emdnCode>
    <emdnDescription>OTHER AUTOMATED SUSCEPTIBILITY TESTING (INCL CONSUMABLES...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPM-NI32</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:53:55.537Z</lastUpdated>
  </row>
  <row>
    <udiDi>15056152702066</udiDi>
    <basicUdiDi>50561527MEC8JV</basicUdiDi>
    <tradeName>15056152702066</tradeName>
    <deviceName>Mast Uri® Plates Mecillinam 8mg/L</deviceName>
    <manufacturerName>Mast Group Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000025209</manufacturerSrn>
    <authorisedRepresentativeName>Mast Diagnostica GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005299</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080113</emdnCode>
    <emdnDescription>OTHER AUTOMATED SUSCEPTIBILITY TESTING (INCL CONSUMABLES...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPM-MEC8</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:53:54.741Z</lastUpdated>
  </row>
  <row>
    <udiDi>15056152702042</udiDi>
    <basicUdiDi>50561527IDM62CU</basicUdiDi>
    <tradeName>15056152702042</tradeName>
    <deviceName>Mast Uri® Plates Chromogenic Group B Strep</deviceName>
    <manufacturerName>Mast Group Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000025209</manufacturerSrn>
    <authorisedRepresentativeName>Mast Diagnostica GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005299</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080113</emdnCode>
    <emdnDescription>OTHER AUTOMATED SUSCEPTIBILITY TESTING (INCL CONSUMABLES...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPM-IDM62</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:53:53.944Z</lastUpdated>
  </row>
  <row>
    <udiDi>15056152701991</udiDi>
    <basicUdiDi>50561527IDM51CP</basicUdiDi>
    <tradeName>15056152701991</tradeName>
    <deviceName>Mast Uri® Plates Aesculin</deviceName>
    <manufacturerName>Mast Group Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000025209</manufacturerSrn>
    <authorisedRepresentativeName>Mast Diagnostica GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005299</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080113</emdnCode>
    <emdnDescription>OTHER AUTOMATED SUSCEPTIBILITY TESTING (INCL CONSUMABLES...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPM-IDM51</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:53:49.935Z</lastUpdated>
  </row>
  <row>
    <udiDi>15056152701946</udiDi>
    <basicUdiDi>50561527GM2S7</basicUdiDi>
    <tradeName>15056152701946</tradeName>
    <deviceName>Mast Uri® Plates Gentamicin 2mg/L</deviceName>
    <manufacturerName>Mast Group Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000025209</manufacturerSrn>
    <authorisedRepresentativeName>Mast Diagnostica GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005299</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080113</emdnCode>
    <emdnDescription>OTHER AUTOMATED SUSCEPTIBILITY TESTING (INCL CONSUMABLES...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPM-GM2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:53:49.136Z</lastUpdated>
  </row>
  <row>
    <udiDi>15056152701878</udiDi>
    <basicUdiDi>50561527CRO1KE</basicUdiDi>
    <tradeName>15056152701878</tradeName>
    <deviceName>Mast Uri® Plates Ceftriaxone 1mg/L</deviceName>
    <manufacturerName>Mast Group Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000025209</manufacturerSrn>
    <authorisedRepresentativeName>Mast Diagnostica GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005299</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080113</emdnCode>
    <emdnDescription>OTHER AUTOMATED SUSCEPTIBILITY TESTING (INCL CONSUMABLES...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPM-CRO1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:53:48.337Z</lastUpdated>
  </row>
</eudamedExport>