<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06934592100593</udiDi>
    <basicUdiDi>B-06934592100593</basicUdiDi>
    <tradeName>One Step LH Ovulation 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>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LHCC40</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T09:12:31.447Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934592100586</udiDi>
    <basicUdiDi>B-06934592100586</basicUdiDi>
    <tradeName>One Step LH Ovulation 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>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LHCC25</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T09:12:30.248Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934592100487</udiDi>
    <basicUdiDi>B-06934592100487</basicUdiDi>
    <tradeName>One Step LH Ovulation 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>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LHCC01</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T09:12:29.050Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934592100470</udiDi>
    <basicUdiDi>B-06934592100470</basicUdiDi>
    <tradeName>One Step LH Ovulation 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>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LHCS100</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T09:12:27.842Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934592100463</udiDi>
    <basicUdiDi>B-06934592100463</basicUdiDi>
    <tradeName>One Step LH Ovulation 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>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LHCS50</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T09:12:26.633Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934592100401</udiDi>
    <basicUdiDi>B-06934592100401</basicUdiDi>
    <tradeName>One Step LH Ovulation 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>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LHCS05</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T09:12:25.432Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934592100098</udiDi>
    <basicUdiDi>B-06934592100098</basicUdiDi>
    <tradeName>Ovulation testing kits</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>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AE67</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T09:12:12.278Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934592100074</udiDi>
    <basicUdiDi>B-06934592100074</basicUdiDi>
    <tradeName>Ovulation testing kits</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>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AE63</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T09:12:08.656Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934142940013</udiDi>
    <basicUdiDi>B-06934142940013</basicUdiDi>
    <tradeName>Digital Ovulation Predictor 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>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10180</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:23:12.323Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934142920077</udiDi>
    <basicUdiDi>B-06934142920077</basicUdiDi>
    <tradeName>Ovulation 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>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14190</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:23:09.926Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934142920060</udiDi>
    <basicUdiDi>B-06934142920060</basicUdiDi>
    <tradeName>Ovulation 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>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14190</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:23:08.724Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934142920053</udiDi>
    <basicUdiDi>B-06934142920053</basicUdiDi>
    <tradeName>Ovulation 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>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10410</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:23:06.325Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934142920046</udiDi>
    <basicUdiDi>B-06934142920046</basicUdiDi>
    <tradeName>OneStep Ovulation Predictor 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>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10470</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:23:05.138Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934142920039</udiDi>
    <basicUdiDi>B-06934142920039</basicUdiDi>
    <tradeName>OneStep Ovulation Predictor 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>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10470</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:23:03.924Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934142920022</udiDi>
    <basicUdiDi>B-06934142920022</basicUdiDi>
    <tradeName>QuikPac OneStep LH 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>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10420</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:23:02.724Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934142920015</udiDi>
    <basicUdiDi>B-06934142920015</basicUdiDi>
    <tradeName>QuikStrip OneStep LH 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>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10400</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:23:01.631Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934078008511</udiDi>
    <basicUdiDi>B-06934078008511</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>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WLH-ES11H</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:22:37.517Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933289810388</udiDi>
    <basicUdiDi>B-06933289810388</basicUdiDi>
    <tradeName>Finecare</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W244</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:06:06.742Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260208449</udiDi>
    <basicUdiDi>B-06933260208449</basicUdiDi>
    <tradeName>LH 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>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT2206</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:00:01.609Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260205639</udiDi>
    <basicUdiDi>B-06933260205639</basicUdiDi>
    <tradeName>LH 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>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0503105</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:54:05.697Z</lastUpdated>
  </row>
</eudamedExport>