<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>
  <row>
    <udiDi>08435287141016</udiDi>
    <basicUdiDi>8435287191iPRO000000V3</basicUdiDi>
    <tradeName>08435287141016</tradeName>
    <deviceName>iPro [IMMUNOFLUORESCENCE PROCESSOR]</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</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>84101</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:47:02.864Z</lastUpdated>
  </row>
  <row>
    <udiDi>08426950643708</udiDi>
    <basicUdiDi>84269506437088U</basicUdiDi>
    <tradeName>NOVA View® AUTOLoader</tradeName>
    <deviceName>NOVA View® AUTOLoader</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>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>ADLR1000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:11:42.699Z</lastUpdated>
  </row>
  <row>
    <udiDi>08059616660506</udiDi>
    <basicUdiDi>805961666PLATEWASHERUP74</basicUdiDi>
    <tradeName>PLATE-WASHER UP</tradeName>
    <deviceName>PLATE-WASHER UP</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>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OR-0100</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:36:24.566Z</lastUpdated>
  </row>
  <row>
    <udiDi>08058945157701</udiDi>
    <basicUdiDi>8058945151EVO.01DV</basicUdiDi>
    <tradeName>EVO SYSTEM PLUS</tradeName>
    <deviceName>Evo System Plus - Evo System Plus</deviceName>
    <manufacturerName>ABD SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000029729</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>1EVO.01</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:16:48.398Z</lastUpdated>
  </row>
  <row>
    <udiDi>16979511570009</udiDi>
    <basicUdiDi>697951157HA001FV</basicUdiDi>
    <tradeName>BIOHIGH-GRADE</tradeName>
    <deviceName>Fully Automated Immunohistochemistry Staining Machine</deviceName>
    <manufacturerName>Beijing High-Grade Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051358</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HGL-60V</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:50:42.958Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978502842074</udiDi>
    <basicUdiDi>697850284SZYYQ04NK</basicUdiDi>
    <tradeName>SMALL DRY FLUORESCENCE IMMUNOASSAY ANALYZER</tradeName>
    <deviceName>SMALL DRY FLUORESCENCE IMMUNOASSAY ANALYZER</deviceName>
    <manufacturerName>Wuhan Life Origin Biotech Joint Stock Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027340</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIC-H0</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:36:45.015Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977981880263</udiDi>
    <basicUdiDi>697798188015W</basicUdiDi>
    <tradeName>Fully Automatic Quantum Dot Fluorescence Immunochromatographic Analyzer</tradeName>
    <deviceName>Fully Automatic Quantum Dot Fluorescence Immunochromatographic Analyzer</deviceName>
    <manufacturerName>Chongqing Juce Life Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000053774</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>J3-E</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:09:09.197Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424223219</udiDi>
    <basicUdiDi>697542422Fluorescence2L</basicUdiDi>
    <tradeName>Fluorescence Immunoassay Analyzer</tradeName>
    <deviceName>Fluorescence Immunoassay Analyzer</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL300</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:57:20.946Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974847813007</udiDi>
    <basicUdiDi>697484781006QA</basicUdiDi>
    <tradeName>ST-36W Microplate Washer</tradeName>
    <deviceName>Microplate Washer</deviceName>
    <manufacturerName>Shanghai Kehua Laboratory System Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017428</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST-36W</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:36:02.490Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974735361115</udiDi>
    <basicUdiDi>697473536KUA06PE</basicUdiDi>
    <tradeName>KEYU Fluorescence Immunoassay Analyzer</tradeName>
    <deviceName>Fluorescent Immunoassay Analyzer</deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</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>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FI-620</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:20:20.409Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974703168098</udiDi>
    <basicUdiDi>697470316m-20LF</basicUdiDi>
    <tradeName>mLabs® Smart</tradeName>
    <deviceName>Fluorescent immunoassay analyser IVD, point-of-care</deviceName>
    <manufacturerName>Micropoint Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007991</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>m-20</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:17:08.902Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974703168081</udiDi>
    <basicUdiDi>697470316m-101HS</basicUdiDi>
    <tradeName>mLabs® ImmunoMeter</tradeName>
    <deviceName>Fluorescent immunoassay analyser IVD, point-of-care</deviceName>
    <manufacturerName>Micropoint Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007991</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>m-101</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:17:07.280Z</lastUpdated>
  </row>
</eudamedExport>