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    <udiDi>06975516220041</udiDi>
    <basicUdiDi>697551622ZXMCDK2B</basicUdiDi>
    <tradeName>06975516220041</tradeName>
    <deviceName>MagPure Circulating DNA Kit</deviceName>
    <manufacturerName>Xiamen Zhixuan Biotech Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000027993</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZEC601（480rxns）</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:13:41.414Z</lastUpdated>
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  <row>
    <udiDi>06975491760112</udiDi>
    <basicUdiDi>697549176DMCTSK</basicUdiDi>
    <tradeName>06975491760112</tradeName>
    <deviceName>DNA Methylation Conversion Kit (Column Test)</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>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20 tests/ kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:10:28.406Z</lastUpdated>
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  <row>
    <udiDi>06975491760068</udiDi>
    <basicUdiDi>697549176NAEAMCK3C</basicUdiDi>
    <tradeName>06975491760068</tradeName>
    <deviceName>Nucleic Acid Extraction and Methylation Conversion Kit</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>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8 tests/ kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:10:27.599Z</lastUpdated>
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  <row>
    <udiDi>06975491760020</udiDi>
    <basicUdiDi>697549176NAEAPK02E3</basicUdiDi>
    <tradeName>06975491760020</tradeName>
    <deviceName>Nucleic Acid Extraction and Purification Kit (Magnetic)</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>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>32 tests/ kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:10:26.816Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975491760006</udiDi>
    <basicUdiDi>697549176NAEAPK01DZ</basicUdiDi>
    <tradeName>06975491760006</tradeName>
    <deviceName>Nucleic Acid Extraction and Purification Kit (Column)</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>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50 tests/ kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:10:26.004Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975461700346</udiDi>
    <basicUdiDi>697546170GeneReadyL3</basicUdiDi>
    <tradeName>06975461700346</tradeName>
    <deviceName>Nucleic Automatic Nucleic Acid Extraction 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>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GeneReady BSH-32</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:05:23.955Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975403050034</udiDi>
    <basicUdiDi>697540305QX2N</basicUdiDi>
    <tradeName>Buffered Cleaning Solution</tradeName>
    <deviceName>Buffered Cleaning Solution</deviceName>
    <manufacturerName>HILEAP Medtech (Nantong) Corp.</manufacturerName>
    <manufacturerSrn>CN-MF-000037836</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>500mL</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:54:20.676Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975403050010</udiDi>
    <basicUdiDi>697540305YX3E</basicUdiDi>
    <tradeName>Sample Diluent</tradeName>
    <deviceName>Sample Diluent</deviceName>
    <manufacturerName>HILEAP Medtech (Nantong) Corp.</manufacturerName>
    <manufacturerSrn>CN-MF-000037836</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0.5mL</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:54:19.871Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974898111732</udiDi>
    <basicUdiDi>697489811000009ZL</basicUdiDi>
    <tradeName>06974898111732</tradeName>
    <deviceName>Reagent for removal of DNA contaminations</deviceName>
    <manufacturerName>GENFINE BIOTECH(CHANGZHOU) CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000003399</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>250mL/bottle</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:40:21.274Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974776970017</udiDi>
    <basicUdiDi>697477697NAEPK019V</basicUdiDi>
    <tradeName>06974776970017</tradeName>
    <deviceName>Nucleic Acid Exctraction/Purification Kit</deviceName>
    <manufacturerName>CapitalBio Genomics Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027716</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>96tests/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:27:40.167Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974735361511</udiDi>
    <basicUdiDi>697473536KUC14PP</basicUdiDi>
    <tradeName>KEYU Cleaning Solution (FI)</tradeName>
    <deviceName>Cleaning Solution (FI)</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>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KU-FW01</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:20:32.415Z</lastUpdated>
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  <row>
    <udiDi>06974735361474</udiDi>
    <basicUdiDi>697473536KUC13PM</basicUdiDi>
    <tradeName>KEYU Iodine Solution</tradeName>
    <deviceName>Iodine Solution</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>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KU-FI01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:20:26.824Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974689624144</udiDi>
    <basicUdiDi>697468962507SE</basicUdiDi>
    <tradeName>Nucleic acid extraction reagent</tradeName>
    <deviceName>Nucleic acid extraction reagent</deviceName>
    <manufacturerName>TargetingOne Technology (Beijing) Corporation</manufacturerName>
    <manufacturerSrn>CN-MF-000028247</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11020</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:15:39.106Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974689624120</udiDi>
    <basicUdiDi>697468962505SA</basicUdiDi>
    <tradeName>Nucleic acid release reagent</tradeName>
    <deviceName>Nucleic acid release reagent</deviceName>
    <manufacturerName>TargetingOne Technology (Beijing) Corporation</manufacturerName>
    <manufacturerSrn>CN-MF-000028247</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11118</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:15:37.529Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974689624106</udiDi>
    <basicUdiDi>697468962504S8</basicUdiDi>
    <tradeName>Nucleic acid extraction reagent (cell DNA)</tradeName>
    <deviceName>Nucleic acid extraction reagent (cell DNA)</deviceName>
    <manufacturerName>TargetingOne Technology (Beijing) Corporation</manufacturerName>
    <manufacturerSrn>CN-MF-000028247</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:15:36.719Z</lastUpdated>
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  <row>
    <udiDi>06974689624090</udiDi>
    <basicUdiDi>697468962520S6</basicUdiDi>
    <tradeName>Nucleic acid extraction reagent</tradeName>
    <deviceName>Nucleic acid extraction reagent</deviceName>
    <manufacturerName>TargetingOne Technology (Beijing) Corporation</manufacturerName>
    <manufacturerSrn>CN-MF-000028247</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11123</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:15:35.113Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974689624083</udiDi>
    <basicUdiDi>697468962511S5</basicUdiDi>
    <tradeName>Nucleic acid release agent (DNA )</tradeName>
    <deviceName>Nucleic acid release agent (DNA )</deviceName>
    <manufacturerName>TargetingOne Technology (Beijing) Corporation</manufacturerName>
    <manufacturerSrn>CN-MF-000028247</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11128</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:15:32.730Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974689624076</udiDi>
    <basicUdiDi>697468962503S6</basicUdiDi>
    <tradeName>Nucleic acid extraction reagent (FFPE DNA)</tradeName>
    <deviceName>Nucleic acid extraction reagent (FFPE DNA)</deviceName>
    <manufacturerName>TargetingOne Technology (Beijing) Corporation</manufacturerName>
    <manufacturerSrn>CN-MF-000028247</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11111</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:15:31.121Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974689624045</udiDi>
    <basicUdiDi>697468962502S4</basicUdiDi>
    <tradeName>Nucleic acid extraction reagent (FFPE TNA)</tradeName>
    <deviceName>Nucleic acid extraction reagent (FFPE TNA)</deviceName>
    <manufacturerName>TargetingOne Technology (Beijing) Corporation</manufacturerName>
    <manufacturerSrn>CN-MF-000028247</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11107</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:15:30.332Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974689624038</udiDi>
    <basicUdiDi>697468962512S7</basicUdiDi>
    <tradeName>Nucleic Acid Extraction Reagent</tradeName>
    <deviceName>Nucleic Acid Extraction Reagent</deviceName>
    <manufacturerName>TargetingOne Technology (Beijing) Corporation</manufacturerName>
    <manufacturerSrn>CN-MF-000028247</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11105</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:15:28.753Z</lastUpdated>
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