<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>09343044002298</udiDi>
    <basicUdiDi>93430440W02039006V6</basicUdiDi>
    <tradeName>HighPlex System</tradeName>
    <deviceName>Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated</deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>R-Biopharm AG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000050025</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02039006</emdnCode>
    <emdnDescription>DNA THERMAL CYCLERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>91501</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:05:16.585Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800317990009</udiDi>
    <basicUdiDi>880031799IP01DY</basicUdiDi>
    <tradeName>I-PREP2</tradeName>
    <deviceName>I-PREP LBC Processor</deviceName>
    <manufacturerName>Imedikers Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000047937</manufacturerSrn>
    <authorisedRepresentativeName>Veritas Eston OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000046695</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02039004</emdnCode>
    <emdnDescription>AUTOMATED SLIDE PREPARATION UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Liquid Based Cytology System I-PREP USER MANUAL Ver.01</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:37:17.871Z</lastUpdated>
  </row>
  <row>
    <udiDi>58059796360857</udiDi>
    <basicUdiDi>805014821IP250CMDSWM02ZA</basicUdiDi>
    <tradeName>PhenoMATRIX</tradeName>
    <deviceName>PhenoMATRIX</deviceName>
    <manufacturerName>Copan Wasp S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000012489</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02039092</emdnCode>
    <emdnDescription>VARIOUS MICROBIOLOGY INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WLAB-PHENOMATRIX</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:36:41.140Z</lastUpdated>
  </row>
  <row>
    <udiDi>58050148211438</udiDi>
    <basicUdiDi>805014821IP040AAUTOM01UB</basicUdiDi>
    <tradeName>WASPLab Single Incubator</tradeName>
    <deviceName>WASPLab System</deviceName>
    <manufacturerName>Copan Wasp S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000012489</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02039099</emdnCode>
    <emdnDescription>VARIOUS MICROBIOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>W087-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:36:32.331Z</lastUpdated>
  </row>
  <row>
    <udiDi>08050054301228</udiDi>
    <basicUdiDi>805005430STR019A9P</basicUdiDi>
    <tradeName>SaCycler-96R Real Time PCR System</tradeName>
    <deviceName>SaCycler-96R Real Time PCR System</deviceName>
    <manufacturerName>Sacace Biotechnologies S.r.l</manufacturerName>
    <manufacturerSrn>IT-MF-000031072</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02039006</emdnCode>
    <emdnDescription>DNA THERMAL CYCLERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC-96R</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:32:02.377Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979232310031</udiDi>
    <basicUdiDi>697923231003KU</basicUdiDi>
    <tradeName>06979232310031</tradeName>
    <deviceName>Metaphase Autospreader</deviceName>
    <manufacturerName>Shanghai LeChen Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051606</manufacturerSrn>
    <authorisedRepresentativeName>Everbiz GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>AT-AR-000035279</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02039004</emdnCode>
    <emdnDescription>AUTOMATED SLIDE PREPARATION UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06979232310031</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:33:00.802Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978507780180</udiDi>
    <basicUdiDi>697850778PXR10Y7</basicUdiDi>
    <tradeName>Thermal Cycler</tradeName>
    <deviceName>Thermal Cycler</deviceName>
    <manufacturerName>Infitek Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048840</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02039006</emdnCode>
    <emdnDescription>DNA THERMAL CYCLERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IN0108</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:37:28.284Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978507780142</udiDi>
    <basicUdiDi>697850778ICB10NP</basicUdiDi>
    <tradeName>CO2 Incubator</tradeName>
    <deviceName>Incubator</deviceName>
    <manufacturerName>Infitek Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048840</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02039002</emdnCode>
    <emdnDescription>CARBON DIOXIDE INCUBATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0302</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:37:21.880Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978230082308</udiDi>
    <basicUdiDi>697823008HE7230A8</basicUdiDi>
    <tradeName>06978230082308</tradeName>
    <deviceName>Slide Stainer Coverslipper Workstation</deviceName>
    <manufacturerName>Shenzhen Beiant Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045896</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02039004</emdnCode>
    <emdnDescription>AUTOMATED SLIDE PREPARATION UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>230</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:23:17.430Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978230081325</udiDi>
    <basicUdiDi>697823008HE6130PBA</basicUdiDi>
    <tradeName>06978230081325</tradeName>
    <deviceName>Slide Stainer Coverslipper Workstation</deviceName>
    <manufacturerName>Shenzhen Beiant Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045896</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02039004</emdnCode>
    <emdnDescription>AUTOMATED SLIDE PREPARATION UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130P</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:23:16.634Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978230081318</udiDi>
    <basicUdiDi>697823008HE6130LB2</basicUdiDi>
    <tradeName>06978230081318</tradeName>
    <deviceName>Slide Stainer Coverslipper Workstation</deviceName>
    <manufacturerName>Shenzhen Beiant Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045896</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02039004</emdnCode>
    <emdnDescription>AUTOMATED SLIDE PREPARATION UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130L</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:23:15.825Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978230081301</udiDi>
    <basicUdiDi>697823008HE61309U</basicUdiDi>
    <tradeName>06978230081301</tradeName>
    <deviceName>Slide Stainer Coverslipper Workstation</deviceName>
    <manufacturerName>Shenzhen Beiant Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045896</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02039004</emdnCode>
    <emdnDescription>AUTOMATED SLIDE PREPARATION UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:23:15.014Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978230081103</udiDi>
    <basicUdiDi>697823008HE61109N</basicUdiDi>
    <tradeName>06978230081103</tradeName>
    <deviceName>Slide Stainer Coverslipper Workstation</deviceName>
    <manufacturerName>Shenzhen Beiant Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045896</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02039004</emdnCode>
    <emdnDescription>AUTOMATED SLIDE PREPARATION UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>110</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:23:11.135Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978230081080</udiDi>
    <basicUdiDi>697823008HE6108A3</basicUdiDi>
    <tradeName>06978230081080</tradeName>
    <deviceName>Slide Stainer Coverslipper Workstation</deviceName>
    <manufacturerName>Shenzhen Beiant Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045896</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02039004</emdnCode>
    <emdnDescription>AUTOMATED SLIDE PREPARATION UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>108</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:23:09.433Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978230080106</udiDi>
    <basicUdiDi>697823008HE60109H</basicUdiDi>
    <tradeName>06978230080106</tradeName>
    <deviceName>Slide Stainer Coverslipper Workstation</deviceName>
    <manufacturerName>Shenzhen Beiant Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045896</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02039004</emdnCode>
    <emdnDescription>AUTOMATED SLIDE PREPARATION UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:23:08.635Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978230080083</udiDi>
    <basicUdiDi>697823008HE60089W</basicUdiDi>
    <tradeName>06978230080083</tradeName>
    <deviceName>Slide Stainer Coverslipper Workstation</deviceName>
    <manufacturerName>Shenzhen Beiant Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045896</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02039004</emdnCode>
    <emdnDescription>AUTOMATED SLIDE PREPARATION UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>008</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:23:07.815Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977908840028</udiDi>
    <basicUdiDi>697790884DCP100005AN</basicUdiDi>
    <tradeName>Digital Colony Picker (DCP)</tradeName>
    <deviceName>Digital Colony Picker (DCP)</deviceName>
    <manufacturerName>Qingdao Single-Cell Biotech. Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000047609</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02039099</emdnCode>
    <emdnDescription>VARIOUS MICROBIOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVDR</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:07:39.402Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977226450497</udiDi>
    <basicUdiDi>697722645BTTC01QD</basicUdiDi>
    <tradeName>Thermal Cycler</tradeName>
    <deviceName>Thermal Cycler</deviceName>
    <manufacturerName>Nanjing Poweam Medical Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000040207</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02039006</emdnCode>
    <emdnDescription>DNA THERMAL CYCLERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WHYA10</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:23:27.219Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976683270020</udiDi>
    <basicUdiDi>697668327NK78</basicUdiDi>
    <tradeName>NK Cell Induction and Expansion Culture Kit</tradeName>
    <deviceName>NK Cell Induction and Expansion Culture Kit</deviceName>
    <manufacturerName>REGEN-αGEEK (SHENZHEN) MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000037130</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02039005</emdnCode>
    <emdnDescription>CULTURE MEDIUM PREPARATION UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Type A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T18:53:35.911Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976683270006</udiDi>
    <basicUdiDi>697668327MSCYL</basicUdiDi>
    <tradeName>Mesenchymal Stem Cell Serum-Free Medium</tradeName>
    <deviceName>Mesenchymal Stem Cell Serum-Free Medium</deviceName>
    <manufacturerName>REGEN-αGEEK (SHENZHEN) MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000037130</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02039005</emdnCode>
    <emdnDescription>CULTURE MEDIUM PREPARATION UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Type A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T18:53:35.128Z</lastUpdated>
  </row>
</eudamedExport>