<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06979822870242</udiDi>
    <basicUdiDi>697982287ZRCP0001UN</basicUdiDi>
    <tradeName>06979822870242</tradeName>
    <deviceName>Integrated Film Processing and Colorization Machine</deviceName>
    <manufacturerName>Cellomics (Shenzhen) Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000028334</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029099</emdnCode>
    <emdnDescription>VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZRCP0001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:47:33.039Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979822870181</udiDi>
    <basicUdiDi>697982287JPCP0001J4</basicUdiDi>
    <tradeName>06979822870181</tradeName>
    <deviceName>Droplet Printer</deviceName>
    <manufacturerName>Cellomics (Shenzhen) Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000028334</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029099</emdnCode>
    <emdnDescription>VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JPCP0001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:47:25.047Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979497340071</udiDi>
    <basicUdiDi>697949734FACA01RM</basicUdiDi>
    <tradeName>06979497340071</tradeName>
    <deviceName>Fully automatic coagulation analyzer</deviceName>
    <manufacturerName>Jiangsu Hongen Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051431</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029099</emdnCode>
    <emdnDescription>VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H1201</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:45:17.642Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979497340019</udiDi>
    <basicUdiDi>697949734FADESRA0139</basicUdiDi>
    <tradeName>06979497340019</tradeName>
    <deviceName>Fully automatic dynamic erythrocyte sedimentation rate analyzer</deviceName>
    <manufacturerName>Jiangsu Hongen Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051431</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029099</emdnCode>
    <emdnDescription>VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HXC-01</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:45:16.838Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978969680004</udiDi>
    <basicUdiDi>697896968Automated3S</basicUdiDi>
    <tradeName>06978969680004</tradeName>
    <deviceName>Automated System for Liquid Based Cell Preparation, Staining and Sealing</deviceName>
    <manufacturerName>Motic (Xiamen) Medical Diagnostic Systems Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000052629</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029099</emdnCode>
    <emdnDescription>VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASPS 9600</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:17:34.611Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977185070002</udiDi>
    <basicUdiDi>697718507KHTPTC</basicUdiDi>
    <tradeName>KUOHAI TECHNOLOGY</tradeName>
    <deviceName>Tissue Processor</deviceName>
    <manufacturerName>Xiaogan Kuohai Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040038</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029099</emdnCode>
    <emdnDescription>VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KH-TB</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:15:19.302Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976241370155</udiDi>
    <basicUdiDi>697624137015KC</basicUdiDi>
    <tradeName>SeekOne™ Microfluidic Control System</tradeName>
    <deviceName>SeekOne™ Microfluidic Control System</deviceName>
    <manufacturerName>Beijing SeekGene BioSciences Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000034144</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029099</emdnCode>
    <emdnDescription>VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M004A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T17:54:09.513Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976241370148</udiDi>
    <basicUdiDi>697624137014KA</basicUdiDi>
    <tradeName>SeekOne™ Digital Droplet System</tradeName>
    <deviceName>SeekOne™ Digital Droplet System</deviceName>
    <manufacturerName>Beijing SeekGene BioSciences Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000034144</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029099</emdnCode>
    <emdnDescription>VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M001A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T17:54:07.915Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975866146633</udiDi>
    <basicUdiDi>697586614MIS007T8</basicUdiDi>
    <tradeName>06975866146633</tradeName>
    <deviceName>Automatic Liquid-Based Cytology Slide Preparation and Staining Machine</deviceName>
    <manufacturerName>Wuhan Landing Intelligence Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030678</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029099</emdnCode>
    <emdnDescription>VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LD-ZR 24</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T17:12:57.426Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972337852222</udiDi>
    <basicUdiDi>697233785i-CheckA012MJ</basicUdiDi>
    <tradeName>06972337852222</tradeName>
    <deviceName>i-Check Blood Gas Analyzer,Handheld</deviceName>
    <manufacturerName>B&amp;E BIO-TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000023256</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029099</emdnCode>
    <emdnDescription>VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>i-Check</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:43:12.302Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972129852027</udiDi>
    <basicUdiDi>697212985BL100094</basicUdiDi>
    <tradeName>Digital Slide Scanning &amp; Imaging System</tradeName>
    <deviceName>Digital Slide Scanning &amp; Imaging System</deviceName>
    <manufacturerName>Hunan Lituo Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000029972</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>W02029099</emdnCode>
    <emdnDescription>VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LTS-BL200</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:34:23.383Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975085645177</udiDi>
    <basicUdiDi>697079159MAPA000A00NE2</basicUdiDi>
    <tradeName>CITOTEST</tradeName>
    <deviceName>Marking Pen</deviceName>
    <manufacturerName>CITOTEST LABWARE MANUFACTURING CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017214</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W02029099</emdnCode>
    <emdnDescription>VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6000-0001</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:31:49.990Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936415988401</udiDi>
    <basicUdiDi>69449040AB3000005ZK</basicUdiDi>
    <tradeName>Automated Digital Cell Morphology Analyzer</tradeName>
    <deviceName>Automated Digital Cell Morphology Analyzer</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029099</emdnCode>
    <emdnDescription>VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MC-80</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:42:02.595Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970413352468</udiDi>
    <basicUdiDi>697041335YGR2003EU8F</basicUdiDi>
    <tradeName>Liquid-based Thin-layer cytology processor</tradeName>
    <deviceName>Liquid-Based Thin-layer Cytology Processor</deviceName>
    <manufacturerName>Hangzhou Yiguoren Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003616</manufacturerSrn>
    <authorisedRepresentativeName>BioDomi GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016611</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029099</emdnCode>
    <emdnDescription>VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YGR-LBC-04</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T00:11:18.639Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970413352420</udiDi>
    <basicUdiDi>697041335YGR2003EU8F</basicUdiDi>
    <tradeName>Liquid-Based Thin-layer Cytology Processor</tradeName>
    <deviceName>Liquid-Based Thin-layer Cytology Processor</deviceName>
    <manufacturerName>Hangzhou Yiguoren Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003616</manufacturerSrn>
    <authorisedRepresentativeName>BioDomi GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016611</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029099</emdnCode>
    <emdnDescription>VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP-20</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T00:11:09.042Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936415988418</udiDi>
    <basicUdiDi>69449040AB3000005ZK</basicUdiDi>
    <tradeName>Automated Digital Cell Morphology Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02029099</emdnCode>
    <emdnDescription>VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MC-82</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:38:21.146Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972129852034</udiDi>
    <basicUdiDi>697212985BL100094</basicUdiDi>
    <tradeName>Digital Slide Scanning &amp; Imaging System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hunan Lituo Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000029972</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>W02029099</emdnCode>
    <emdnDescription>VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LTS-BL400</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:37:40.121Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972129852041</udiDi>
    <basicUdiDi>697212985BL100094</basicUdiDi>
    <tradeName>Digital Slide Scanning &amp; Imaging System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hunan Lituo Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000029972</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>W02029099</emdnCode>
    <emdnDescription>VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LTS-BL600</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:37:40.099Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972129852058</udiDi>
    <basicUdiDi>697212985BL100094</basicUdiDi>
    <tradeName>Digital Slide Scanning &amp; Imaging System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hunan Lituo Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000029972</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>W02029099</emdnCode>
    <emdnDescription>VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LTS-BL1000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:37:40.079Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972337852239</udiDi>
    <basicUdiDi>697233785i-CheckA012MJ</basicUdiDi>
    <tradeName>06972337852239</tradeName>
    <deviceName></deviceName>
    <manufacturerName>B&amp;E BIO-TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000023256</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029099</emdnCode>
    <emdnDescription>VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>i-Check 200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:36:00.987Z</lastUpdated>
  </row>
</eudamedExport>