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<eudamedExport entity="devices">
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    <udiDi>06977211621055</udiDi>
    <basicUdiDi>697721162HSELBCPKB2</basicUdiDi>
    <tradeName>Healthsky</tradeName>
    <deviceName>EASY-TLT Liquid-Based Cytology Processing Kit</deviceName>
    <manufacturerName>Hangzhou HealthSky Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040002</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>FGA01-1B</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:19:49.296Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977211620058</udiDi>
    <basicUdiDi>697721162HSLBCPKX3</basicUdiDi>
    <tradeName>Healthsky</tradeName>
    <deviceName>Liquid-Based Cytology Processing Kit</deviceName>
    <manufacturerName>Hangzhou HealthSky Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040002</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>FGA01-1AP</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:19:48.503Z</lastUpdated>
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    <udiDi>06976014640010</udiDi>
    <basicUdiDi>697601464NAEK01FW</basicUdiDi>
    <tradeName>CHK Biotech</tradeName>
    <deviceName>Nucleic Acid Extraction Kit (Magnetic Beads)</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>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-02T17:34:07.124Z</lastUpdated>
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    <udiDi>06975970650071</udiDi>
    <basicUdiDi>697597065023QJ</basicUdiDi>
    <tradeName>cfDNA Isolation Kit (Magnetic Beads)</tradeName>
    <deviceName>cfDNA Isolation Kit (Magnetic Beads)</deviceName>
    <manufacturerName>SINGLERA GENOMICS (JIANGSU) LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000033428</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>EP120048CE</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T17:27:29.853Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975970650057</udiDi>
    <basicUdiDi>697597065022QG</basicUdiDi>
    <tradeName>Bisulfite Conversion Kit (Spin Column)</tradeName>
    <deviceName>Bisulfite Conversion Kit (Spin Column)</deviceName>
    <manufacturerName>SINGLERA GENOMICS (JIANGSU) LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000033428</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>EP110048CE</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T17:27:28.258Z</lastUpdated>
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  <row>
    <udiDi>06975938850000</udiDi>
    <basicUdiDi>697593885NAEAPRZ8</basicUdiDi>
    <tradeName>Baybio</tradeName>
    <deviceName>Nucleic Acid Extraction and Purification Reagents</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>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T17:25:13.629Z</lastUpdated>
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    <udiDi>06975866141614</udiDi>
    <basicUdiDi>697586614MIS005T4</basicUdiDi>
    <tradeName>Landing</tradeName>
    <deviceName>Liquid Based Cervical Cytology Kit</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>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T17:12:48.634Z</lastUpdated>
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  <row>
    <udiDi>06975621460004</udiDi>
    <basicUdiDi>697562146YUR03U7</basicUdiDi>
    <tradeName>06975621460004</tradeName>
    <deviceName>Nucleic Acid Extraction Kit (Magnetic Bead Method)</deviceName>
    <manufacturerName>Jiangsu Yu An Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020608</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>2026-07-02T16:26:18.470Z</lastUpdated>
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  <row>
    <udiDi>06975573960058</udiDi>
    <basicUdiDi>697557396bwyx005MH</basicUdiDi>
    <tradeName>BEIWO</tradeName>
    <deviceName>FFPE Tissue gDNA Isolation Kit (Beads)</deviceName>
    <manufacturerName>Hangzhou Beiwo Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027312</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>BW-MGD2212-A32</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:18:07.473Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975573960034</udiDi>
    <basicUdiDi>697557396bwyx003MD</basicUdiDi>
    <tradeName>BEIWO</tradeName>
    <deviceName>Saliva gDNA Isolation Kit (Beads)</deviceName>
    <manufacturerName>Hangzhou Beiwo Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027312</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>BW-MGD2318-A32</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:18:05.866Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975573960041</udiDi>
    <basicUdiDi>697557396bwyx004MF</basicUdiDi>
    <tradeName>BEIWO</tradeName>
    <deviceName>Express MgPure Viral RNA Purification Kit (Beads)</deviceName>
    <manufacturerName>Hangzhou Beiwo Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027312</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>BW-MR6532-A32</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:18:05.063Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975573960010</udiDi>
    <basicUdiDi>697557396bwyx001M9</basicUdiDi>
    <tradeName>BEIWO</tradeName>
    <deviceName>Viral DNA/RNA Purification Kit (Beads)</deviceName>
    <manufacturerName>Hangzhou Beiwo Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027312</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>BW-MR6536-A32</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:18:03.454Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975573960027</udiDi>
    <basicUdiDi>697557396bwyx002MB</basicUdiDi>
    <tradeName>BEIWO</tradeName>
    <deviceName>Blood gDNA Isolation Kit (Beads)</deviceName>
    <manufacturerName>Hangzhou Beiwo Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027312</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>BW-MGD2311-A32</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:18:01.136Z</lastUpdated>
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  <row>
    <udiDi>06975573960003</udiDi>
    <basicUdiDi>697557396bwyx007MM</basicUdiDi>
    <tradeName>BEIWO</tradeName>
    <deviceName>Pathogen DNA/RNA Purification Kit (Beads)</deviceName>
    <manufacturerName>Hangzhou Beiwo Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027312</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>BW-MGD2411-A00</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:17:47.400Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975516220072</udiDi>
    <basicUdiDi>697551622ZXUDLPKJ9</basicUdiDi>
    <tradeName>06975516220072</tradeName>
    <deviceName>Universal DNA Library Prep 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>ZD101-01(24rxns)</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:13:42.216Z</lastUpdated>
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  <row>
    <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>
  </row>
  <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>
  </row>
  <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>
  </row>
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    <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>
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</eudamedExport>