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<eudamedExport entity="devices">
  <row>
    <udiDi>06934142910085</udiDi>
    <basicUdiDi>B-06934142910085</basicUdiDi>
    <tradeName>Pregnancy Test Strips</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tianjin New Bay Bioresearch Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040564</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9010</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:22:54.309Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934142910078</udiDi>
    <basicUdiDi>B-06934142910078</basicUdiDi>
    <tradeName>OneStep Pregnancy Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tianjin New Bay Bioresearch Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040564</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10120</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:22:53.140Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934142910061</udiDi>
    <basicUdiDi>B-06934142910061</basicUdiDi>
    <tradeName>QuikPac OneStep HCG Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tianjin New Bay Bioresearch Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040564</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7010</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:22:52.004Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934142910054</udiDi>
    <basicUdiDi>B-06934142910054</basicUdiDi>
    <tradeName>QuikStrip OneStep HCG Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tianjin New Bay Bioresearch Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040564</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9001</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:22:50.717Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934142910047</udiDi>
    <basicUdiDi>B-06934142910047</basicUdiDi>
    <tradeName>TEST DE GROSSESSE DÉ TECTION PRÉCOCE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tianjin New Bay Bioresearch Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040564</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10156</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:22:49.535Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934142910030</udiDi>
    <basicUdiDi>B-06934142910030</basicUdiDi>
    <tradeName>Pregnancy Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tianjin New Bay Bioresearch Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040564</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10157</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:22:48.443Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934142910016</udiDi>
    <basicUdiDi>B-06934142910016</basicUdiDi>
    <tradeName>Pregnancy Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tianjin New Bay Bioresearch Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040564</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10155</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:22:44.721Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934078008528</udiDi>
    <basicUdiDi>B-06934078008528</basicUdiDi>
    <tradeName>TRIGNOSTICS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WHCG-EM11</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:22:38.713Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260208401</udiDi>
    <basicUdiDi>B-06933260208401</basicUdiDi>
    <tradeName>β-HCG Rapid Quantitative Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT2202</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:59:56.812Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260205882</udiDi>
    <basicUdiDi>B-06933260205882</basicUdiDi>
    <tradeName>β-HCG Rapid Quantitative Test (Chemiluminescence Immunoassay)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0503605</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:54:43.256Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260205875</udiDi>
    <basicUdiDi>B-06933260205875</basicUdiDi>
    <tradeName>β-HCG Rapid Quantitative Test (Chemiluminescence Immunoassay)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0503604</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:54:40.529Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260205868</udiDi>
    <basicUdiDi>B-06933260205868</basicUdiDi>
    <tradeName>β-HCG Rapid Quantitative Test (Chemiluminescence Immunoassay)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0503603</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:54:39.527Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260205851</udiDi>
    <basicUdiDi>B-06933260205851</basicUdiDi>
    <tradeName>β-HCG Rapid Quantitative Test (Chemiluminescence Immunoassay)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0503602</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:54:38.115Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260205844</udiDi>
    <basicUdiDi>B-06933260205844</basicUdiDi>
    <tradeName>β-HCG Rapid Quantitative Test (Chemiluminescence Immunoassay)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0503601</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:54:36.923Z</lastUpdated>
  </row>
  <row>
    <udiDi>06438115001201</udiDi>
    <basicUdiDi>B-06438115001201</basicUdiDi>
    <tradeName>Facit hCG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aidian Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000023611</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>149737</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:07:44.979Z</lastUpdated>
  </row>
  <row>
    <udiDi>05902643958142</udiDi>
    <basicUdiDi>59026439BRT307JJ</basicUdiDi>
    <tradeName>05902643958142</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1-307-P050</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:11:09.919Z</lastUpdated>
  </row>
  <row>
    <udiDi>16976838230036</udiDi>
    <basicUdiDi>697683823P201600ES</basicUdiDi>
    <tradeName>GenSure HCG Pregnancy Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GenSure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000028354</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P2016M02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T00:45:06.588Z</lastUpdated>
  </row>
  <row>
    <udiDi>16976838230043</udiDi>
    <basicUdiDi>697683823P201600ES</basicUdiDi>
    <tradeName>GenSure HCG Pregnancy Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GenSure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000028354</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P2016M03</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T00:45:06.563Z</lastUpdated>
  </row>
  <row>
    <udiDi>16976838230050</udiDi>
    <basicUdiDi>697683823P201600ES</basicUdiDi>
    <tradeName>GenSure HCG Pregnancy Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GenSure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000028354</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P2016M05</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T00:45:06.542Z</lastUpdated>
  </row>
  <row>
    <udiDi>16976838230067</udiDi>
    <basicUdiDi>697683823P201600ES</basicUdiDi>
    <tradeName>GenSure HCG Pregnancy Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GenSure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000028354</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P2016M25</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T00:45:06.520Z</lastUpdated>
  </row>
</eudamedExport>