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<eudamedExport entity="devices">
  <row>
    <udiDi>06936155803576</udiDi>
    <basicUdiDi>B-06936155803576</basicUdiDi>
    <tradeName>ONE STEP Pregnancy (hCG) Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>InTec PRODUCTS, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000023625</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITP04002-TC40</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:12:24.619Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936155803484</udiDi>
    <basicUdiDi>B-06936155803484</basicUdiDi>
    <tradeName>ONE STEP Pregnancy (hCG) Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>InTec PRODUCTS, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000023625</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITP04002-DS50</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:12:21.026Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935091671980</udiDi>
    <basicUdiDi>B-06935091671980</basicUdiDi>
    <tradeName>One Step HCG Urine Pregnancy Rapid Test Kit (Colloidal Gold)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Qingdao Hightop Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016890</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:39:47.301Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934592100364</udiDi>
    <basicUdiDi>B-06934592100364</basicUdiDi>
    <tradeName>One Step HCG Pregnancy Test (Colloidal Gold)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nantong Diagnos Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041526</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HCGCM25</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T09:12:24.345Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934592100272</udiDi>
    <basicUdiDi>B-06934592100272</basicUdiDi>
    <tradeName>One Step HCG Pregnancy Test (Colloidal Gold)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nantong Diagnos Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041526</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HCGCM02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T09:12:21.848Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934592100265</udiDi>
    <basicUdiDi>B-06934592100265</basicUdiDi>
    <tradeName>One Step HCG Pregnancy Test (Colloidal Gold)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nantong Diagnos Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041526</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HCGCM01</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T09:12:20.655Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934592100258</udiDi>
    <basicUdiDi>B-06934592100258</basicUdiDi>
    <tradeName>One Step HCG Pregnancy Test (Colloidal Gold)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nantong Diagnos Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041526</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HCGCC40</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T09:12:19.460Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934592100241</udiDi>
    <basicUdiDi>B-06934592100241</basicUdiDi>
    <tradeName>One Step HCG Pregnancy Test (Colloidal Gold)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nantong Diagnos Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041526</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HCGCC25</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T09:12:18.245Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934592100142</udiDi>
    <basicUdiDi>B-06934592100142</basicUdiDi>
    <tradeName>One Step HCG Pregnancy Test (Colloidal Gold)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nantong Diagnos Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041526</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HCGCC01</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T09:12:15.845Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934592100135</udiDi>
    <basicUdiDi>B-06934592100135</basicUdiDi>
    <tradeName>One Step HCG Pregnancy Test (Colloidal Gold)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nantong Diagnos Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041526</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HCGCS100</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T09:12:14.642Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934592100128</udiDi>
    <basicUdiDi>B-06934592100128</basicUdiDi>
    <tradeName>One Step HCG Pregnancy Test (Colloidal Gold)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nantong Diagnos Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041526</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HCGCS50</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T09:12:13.458Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934592100067</udiDi>
    <basicUdiDi>B-06934592100067</basicUdiDi>
    <tradeName>Pregnancy testing kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nantong Diagnos Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041526</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AE62</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T09:12:07.477Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934592100050</udiDi>
    <basicUdiDi>B-06934592100050</basicUdiDi>
    <tradeName>Pregnancy testing kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nantong Diagnos Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041526</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AE61</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T09:12:06.263Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934592100012</udiDi>
    <basicUdiDi>B-06934592100012</basicUdiDi>
    <tradeName>ORYVA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nantong Diagnos Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041526</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HCGCM01</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T09:12:05.065Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934142930014</udiDi>
    <basicUdiDi>B-06934142930014</basicUdiDi>
    <tradeName>Digital 1 Step 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>10170</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:23:11.121Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934142910023</udiDi>
    <basicUdiDi>B-06934142910023</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>2026-06-24T08:23:07.519Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934142910122</udiDi>
    <basicUdiDi>B-06934142910122</basicUdiDi>
    <tradeName>Test de grossesse</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>10162</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:22:59.111Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934142910115</udiDi>
    <basicUdiDi>B-06934142910115</basicUdiDi>
    <tradeName>Test de grossesse</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>10162</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:22:57.912Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934142910108</udiDi>
    <basicUdiDi>B-06934142910108</basicUdiDi>
    <tradeName>Pregnancy Tests</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>10161</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:22:56.716Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934142910092</udiDi>
    <basicUdiDi>B-06934142910092</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>10161</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:22:55.507Z</lastUpdated>
  </row>
</eudamedExport>