<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08684998275996</udiDi>
    <basicUdiDi>868459503MGX32QC</basicUdiDi>
    <tradeName>MagPro™ Magnetic Bead-Based Automated NA Extraction System - MGX-32</tradeName>
    <deviceName>Magnetic Bead-Based Automated NA Extraction System - MGX-32</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050399</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS - RAPID AND POINT OF CARE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MGX-32</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:39:40.996Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684595032350</udiDi>
    <basicUdiDi>868459503MGX16QE</basicUdiDi>
    <tradeName>MagPro™ Magnetic Bead-Based Automated NA Extraction System - MGX-16</tradeName>
    <deviceName>Magnetic Bead-Based Automated NA Extraction System - MGX-16</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050399</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS - RAPID AND POINT OF CARE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MGX-16</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:37:24.326Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684595032343</udiDi>
    <basicUdiDi>868459503MGX2RM</basicUdiDi>
    <tradeName>MagPro™ Magnetic Bead-Based Automated NA Extraction System - MGX-2</tradeName>
    <deviceName>Magnetic Bead-Based Automated NA Extraction System - MGX-2</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050399</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS - RAPID AND POINT OF CARE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MGX-2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:37:21.588Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979117020024</udiDi>
    <basicUdiDi>697911702GS002ES</basicUdiDi>
    <tradeName>06979117020024</tradeName>
    <deviceName>Flow Cell</deviceName>
    <manufacturerName>Geneus Technologies (Chengdu) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000050313</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050385</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS - RAPID AND POINT OF CARE TESTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G-MK02</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:26:20.124Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979117020017</udiDi>
    <basicUdiDi>697911702GS001EQ</basicUdiDi>
    <tradeName>06979117020017</tradeName>
    <deviceName>G-seq500 Single Molecule Sequencer</deviceName>
    <manufacturerName>Geneus Technologies (Chengdu) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000050313</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050301</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G-seq500</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:26:19.319Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978507780173</udiDi>
    <basicUdiDi>697850778PCR10TL</basicUdiDi>
    <tradeName>Real-time PCR System</tradeName>
    <deviceName>Real-time PCR System</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>W02050301</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IN0109</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:37:27.480Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978380060003</udiDi>
    <basicUdiDi>697838006CHMINIPCRYM</basicUdiDi>
    <tradeName>06978380060003</tradeName>
    <deviceName>Mini PCR</deviceName>
    <manufacturerName>Suzhou Changhe Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045901</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050301</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HTM-8T</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:29:34.763Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978022400013</udiDi>
    <basicUdiDi>69780224000137D</basicUdiDi>
    <tradeName>06978022400013</tradeName>
    <deviceName>Automatic nucleic acid extractor</deviceName>
    <manufacturerName>Contin Instrument (Suzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045197</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050392</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS - RAPID AND POINT OF CARE TESTS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06978022400013</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:09:40.409Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977537461755</udiDi>
    <basicUdiDi>697753746CW07RE</basicUdiDi>
    <tradeName>NATBox System</tradeName>
    <deviceName>NATBox System</deviceName>
    <manufacturerName>Taizhou Cowingene Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042619</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050301</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CW07023Q</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:41:14.123Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977426530005</udiDi>
    <basicUdiDi>6977426530015D2</basicUdiDi>
    <tradeName>06977426530005</tradeName>
    <deviceName>Nucleic Acid Extractor</deviceName>
    <manufacturerName>Guangzhou Four E’s Scientific Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000043042</manufacturerSrn>
    <authorisedRepresentativeName>Humiss Beratung GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000023447</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050301</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MultiEX 024L，MultiEX 016，MultiEX 096P</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:34:10.311Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976055490162</udiDi>
    <basicUdiDi>697605549002LT</basicUdiDi>
    <tradeName>06976055490162</tradeName>
    <deviceName>Auto Quantitative PCR System</deviceName>
    <manufacturerName>GUANGZHOU DEAOU GENE TECHNOLOGY CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000033028</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050301</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Deaou-ART04</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T17:37:35.421Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976055490018</udiDi>
    <basicUdiDi>697605549001LR</basicUdiDi>
    <tradeName>06976055490018</tradeName>
    <deviceName>Real-Time Fluorescent Quantitative PCR System</deviceName>
    <manufacturerName>GUANGZHOU DEAOU GENE TECHNOLOGY CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000033028</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050301</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T17:37:33.030Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976014643011</udiDi>
    <basicUdiDi>697601464RFQPS012B</basicUdiDi>
    <tradeName>CHK Biotech</tradeName>
    <deviceName>Real-time Fluorescence Quantitative PCR System</deviceName>
    <manufacturerName>Shanghai Chuangkun Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000032705</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050301</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-02T17:34:12.707Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976014642014</udiDi>
    <basicUdiDi>697601464TFFQPS01EW</basicUdiDi>
    <tradeName>CHK Biotech</tradeName>
    <deviceName>Thunder Fast Fluorescence Quantitative PCR System</deviceName>
    <manufacturerName>Shanghai Chuangkun Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000032705</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050301</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-02T17:34:12.041Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975938851052</udiDi>
    <basicUdiDi>697593885ANAISV9</basicUdiDi>
    <tradeName>06975938851052</tradeName>
    <deviceName>Automated Nucleic Acid Isolation System</deviceName>
    <manufacturerName>GUANGZHOU BAYBIO BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000030650</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050301</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NE-12-T-24</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T17:25:17.617Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975614169044</udiDi>
    <basicUdiDi>697561416NAT1N7</basicUdiDi>
    <tradeName>06975614169044</tradeName>
    <deviceName>Fully-Automated Nucleic Acid Amplification Testing System</deviceName>
    <manufacturerName>Genewise Bio Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000038313</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050399</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS - RAPID AND POINT OF CARE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NAT-3000</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:24:15.068Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975491760174</udiDi>
    <basicUdiDi>697549176ADEAMIPM</basicUdiDi>
    <tradeName>06975491760174</tradeName>
    <deviceName>Automatic DNA Extraction and Methylation instrument</deviceName>
    <manufacturerName>Shenzhen Sciarray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000038307</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050399</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS - RAPID AND POINT OF CARE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SEP-8</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:10:33.212Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975461700377</udiDi>
    <basicUdiDi>697546170QuantReadyKZ</basicUdiDi>
    <tradeName>06975461700377</tradeName>
    <deviceName>Real-Time Fluorescence Quantitative PCR system</deviceName>
    <manufacturerName>Hangzhou Lifereal Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019191</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050301</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QuantReady K9600</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:05:24.751Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975327120066</udiDi>
    <basicUdiDi>697532712PM001FP</basicUdiDi>
    <tradeName>Mini Dock</tradeName>
    <deviceName>Integrated Nucleic Acid Testing Device</deviceName>
    <manufacturerName>Guangzhou Pluslife Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000025784</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050301</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PM001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:37:35.416Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975196540088</udiDi>
    <basicUdiDi>697519654829QC</basicUdiDi>
    <tradeName>06975196540088</tradeName>
    <deviceName>Isothermal Nucleic Acid Amplification Detector</deviceName>
    <manufacturerName>Wuxi Qitian Biological Science Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023012</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050301</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>829</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:24:18.199Z</lastUpdated>
  </row>
</eudamedExport>