<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06926980315368</udiDi>
    <basicUdiDi>69269803YQHiLIA1250i3F</basicUdiDi>
    <tradeName>HiLIA 1250i</tradeName>
    <deviceName>Fully Automatic Immunoblotting Analyser</deviceName>
    <manufacturerName>Guangzhou Kangrun Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032267</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CK-KR-BLOT-005</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:42:15.087Z</lastUpdated>
  </row>
  <row>
    <udiDi>06921807605035</udiDi>
    <basicUdiDi>692180760503F6</basicUdiDi>
    <tradeName>Fluorescence Immunoassay Analyzer LEPU Quant 1600</tradeName>
    <deviceName>Fluorescence Immunoassay Analyzer LEPU Quant 1600</deviceName>
    <manufacturerName>BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000033011</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JY20LEPUQuant-Fluo1600</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:11:12.652Z</lastUpdated>
  </row>
  <row>
    <udiDi>06921807600726</udiDi>
    <basicUdiDi>692180760072EY</basicUdiDi>
    <tradeName>Fluorescence immunochromatography analyzer LEPU Quant-Fluo800</tradeName>
    <deviceName>Fluorescence immunochromatography analyzer LEPU Quant-Fluo800</deviceName>
    <manufacturerName>BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000033011</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JY05LEPU Quant-Fluo 800</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:11:06.241Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055273209952</udiDi>
    <basicUdiDi>50552732AEVINVE026MR</basicUdiDi>
    <tradeName>evidence INVESTIGATOR</tradeName>
    <deviceName>evidence INVESTIGATOR</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EV3602</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:12:00.069Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895301660</udiDi>
    <basicUdiDi>06936895BS016K4</basicUdiDi>
    <tradeName>Specific Protein Analyzer</tradeName>
    <deviceName>Specific Protein Analyzer</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BK-PA120</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:52:09.897Z</lastUpdated>
  </row>
  <row>
    <udiDi>04033145036418</udiDi>
    <basicUdiDi>04033145EL18460K5</basicUdiDi>
    <tradeName>CombiWash</tradeName>
    <deviceName>CombiWash</deviceName>
    <manufacturerName>Human Gesellschaft für Biochemica und Diagnostica mbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025590</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18460</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:26:47.221Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971348763350</udiDi>
    <basicUdiDi>697134876302A3350XL</basicUdiDi>
    <tradeName>Dry-type Immunofluorescence Analyzer</tradeName>
    <deviceName>Dry-type Immunofluorescence Analyzer</deviceName>
    <manufacturerName>Shenzhen Microprofit Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000019518</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MF-902</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:05:08.019Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69717712029529U</udiDi>
    <basicUdiDi>B-69717712029529U</basicUdiDi>
    <tradeName>LYSUN</tradeName>
    <deviceName>Influenza A+B/ COVID-19/ RSV/HMPV Antigen Rapid Test Device</deviceName>
    <manufacturerName>Hangzhou Lysun Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010254</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCRH-S25（1PCS）</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:00:42.628Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69717712025949Q</udiDi>
    <basicUdiDi>B-69717712025949Q</basicUdiDi>
    <tradeName>LYSUN</tradeName>
    <deviceName>Influenza A+B/ COVID-19/ RSV/ADV/HMPV Antigen Rapid Test</deviceName>
    <manufacturerName>Hangzhou Lysun Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010254</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCRAH-S26（1PCS）</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:00:38.654Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69717712023899M</udiDi>
    <basicUdiDi>B-69717712023899M</basicUdiDi>
    <tradeName>LYSUN</tradeName>
    <deviceName>COVID-19 Antigen Rapid Test Device(Colloidal Gold)</deviceName>
    <manufacturerName>Hangzhou Lysun Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010254</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COV-201（1PCS）</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:00:37.129Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6971771201979A9</udiDi>
    <basicUdiDi>B-6971771201979A9</basicUdiDi>
    <tradeName>LYSUN</tradeName>
    <deviceName>SARS-CoV-2 &amp; Flu A/B Rapid Antigen Test</deviceName>
    <manufacturerName>Hangzhou Lysun Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010254</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCR-S23（1PCS）</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:59:12.064Z</lastUpdated>
  </row>
  <row>
    <udiDi>6971771200859</udiDi>
    <basicUdiDi>B-6971771200859</basicUdiDi>
    <tradeName>Influenza A+B/COVID-19/ RSV Antigen Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Lysun Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010254</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Influenza A+B/ COVID-19/ RSV Antigen Rapid Test</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:50:51.292Z</lastUpdated>
  </row>
  <row>
    <udiDi>++G580XZELLCryostainerB3R1</udiDi>
    <basicUdiDi>++G580XZELLCryostainerB3R</basicUdiDi>
    <tradeName>Cryostainer</tradeName>
    <deviceName>Cryostainer &amp; Accessories</deviceName>
    <manufacturerName>X-ZELL Biotech Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000039227</manufacturerSrn>
    <authorisedRepresentativeName>X-ZELL Biotech GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000039132</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XZ1023</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T18:20:59.383Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977254770109</udiDi>
    <basicUdiDi>B-06977254770109</basicUdiDi>
    <tradeName>06977254770109</tradeName>
    <deviceName>Hailife POC Hematology Analyzer</deviceName>
    <manufacturerName>Shenzhen Hailife Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042748</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:17:24.807Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977254770093</udiDi>
    <basicUdiDi>B-06977254770093</basicUdiDi>
    <tradeName>06977254770093</tradeName>
    <deviceName>Hailife POC Hematology Analyer</deviceName>
    <manufacturerName>Shenzhen Hailife Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042748</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:17:24.018Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800066300005</udiDi>
    <basicUdiDi>8800066300005WS</basicUdiDi>
    <tradeName>ASFA Scanner</tradeName>
    <deviceName>Immunofluorescence measuring device</deviceName>
    <manufacturerName>MBD Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000026682</manufacturerSrn>
    <authorisedRepresentativeName>Javitech Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000045915</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>MBD-SC4C-S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:27:17.432Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435421271890</udiDi>
    <basicUdiDi>8435421200571Y8</basicUdiDi>
    <tradeName>master diagnóstica</tradeName>
    <deviceName>VitroStainer 42 / NeoPATH Pro</deviceName>
    <manufacturerName>VITRO, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000001498</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VIT-VS42</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:04:11.281Z</lastUpdated>
  </row>
  <row>
    <udiDi>8435287392203</udiDi>
    <basicUdiDi>843528739220HK</basicUdiDi>
    <tradeName>SAGA with Incubator</tradeName>
    <deviceName>SAGA with Incubator</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>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6802051</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:58:16.224Z</lastUpdated>
  </row>
  <row>
    <udiDi>8435287392104</udiDi>
    <basicUdiDi>843528739210HG</basicUdiDi>
    <tradeName>SAGA    ELISA Microplate Washer</tradeName>
    <deviceName>SAGA    ELISA Microplate Washer</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>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6802050</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:58:14.623Z</lastUpdated>
  </row>
  <row>
    <udiDi>8435287392005</udiDi>
    <basicUdiDi>843528739200HD</basicUdiDi>
    <tradeName>GEA      ELISA Microplate Reader</tradeName>
    <deviceName>GEA - Microplate Reader</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>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6802000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:58:12.222Z</lastUpdated>
  </row>
</eudamedExport>